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OpenTrials
Completed

NCT Number: NCT00150709

A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

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Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
  • Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion criteria

  • Not be on a ketogenic diet (during the course of this study).
  • Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Treatment and study plan

Levetiracetam

Drug
  • Pharmaceutical form: Oral tablets and oral solution
  • Route of administration: Oral use

Other names: Keppra

Primary outcomes

  1. Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

  2. Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline.

Secondary outcomes

  1. Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    Absolute change from Baseline of Partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

  2. Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    Absolute change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate improvement from Baseline.

  3. At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    At least 50% responder rate in Partial Onset (Type I) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in Partial Onset (Type I) seizure frequency of at least 50%. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures).

  4. At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years), compared to Baseline

    At least 50% responder rate in total (Type I, II, III) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in total (Type I, II, III) seizure frequency of at least 50%. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification.

  5. Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years)

    A day was considered seizure-free if no seizures were reported for 24 hours.

  6. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0)

    Time frame: Day 0 (beginning day of the maintenance phase)

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  7. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months)

    Time frame: Day 1 - <= 2 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  8. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months)

    Time frame: > 2 months - <= 4 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  9. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months)

    Time frame: > 4 months - <= 6 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  10. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months)

    Time frame: > 6 months - <= 8 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  11. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months)

    Time frame: > 8 months - <= 10 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  12. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months)

    Time frame: > 10 months - <= 12 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  13. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months)

    Time frame: > 12 months - <= 14 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  14. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months)

    Time frame: > 14 months - <= 16 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  15. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months)

    Time frame: > 16 months - <= 18 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  16. Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months)

    Time frame: > 18 months - <= 20 months of the Maintenance Phase

    A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

  17. Number of Seizures by Type During the Treatment Period

    Time frame: During the Treatment Period (an average of 2 years)

    Number of following seizure types were assessed: Total seizures (Type I, II, III), Total Type I seizures, Total Type II seizures, Total Type III seizures

  18. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1

    Time frame: Visit 1 (Screening Visit (Week 0))

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.

  19. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1

    Time frame: Titration Visit 1 (Week 2)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  20. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2

    Time frame: Titration Visit 2 (Week 4)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  21. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3

    Time frame: Titration Visit 3 (Week 6)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  22. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2

    Time frame: Visit 2 (Month 2)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  23. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3

    Time frame: Visit 3 (Month 4)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  24. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4

    Time frame: Visit 4 (Month 6)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  25. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5

    Time frame: Visit 5 (Month 9)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  26. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6

    Time frame: Visit 6 (Month 12)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  27. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7

    Time frame: Visit 7 (Month 15)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  28. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8

    Time frame: Visit 8 (Month 18)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  29. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9

    Time frame: Visit 9 (Month 21)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  30. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10

    Time frame: Visit 10 (Month 24)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  31. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11

    Time frame: Visit 11 (Month 27)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  32. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12

    Time frame: Visit 12 (Month 30)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  33. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13

    Time frame: Visit 13 (Month 33)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  34. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14

    Time frame: Visit 14 (Month 36)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  35. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15

    Time frame: Visit 15 (Month 39)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  36. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16

    Time frame: Visit 16 (Month 42)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  37. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17

    Time frame: Visit 17 (Month 45)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  38. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18

    Time frame: Visit 18 (Month 48)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  39. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19

    Time frame: Visit 19 (Month 51)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  40. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20

    Time frame: Visit 20 (Month 54)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  41. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21

    Time frame: Visit 21 (Month 57)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  42. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22

    Time frame: Visit 22 (Month 60)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  43. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23

    Time frame: Visit 23 (Month 63)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  44. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24

    Time frame: Visit 24 (Month 66)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  45. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25

    Time frame: Visit 25 (Month 69)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  46. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26

    Time frame: Visit 26 (Month 72)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  47. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27

    Time frame: Visit 27 (Month 75)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  48. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28

    Time frame: Visit 28 (Month 78)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  49. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29

    Time frame: Visit 29 (Month 81)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  50. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30

    Time frame: Visit 30 (Month 84)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  51. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31

    Time frame: Visit 31 (Month 87)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  52. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit

    Time frame: Withdrawal visit (up to Month 90)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  53. Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit

    Time frame: Final visit (up to Month 90)

    Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  54. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1

    Time frame: Visit 1 (Screening Visit (Week 0))

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.

  55. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1

    Time frame: Titration Visit 1 (Week 2)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  56. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2

    Time frame: Titration Visit 2 (Week 4)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  57. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3

    Time frame: Titration Visit 3 (Week 6)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  58. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2

    Time frame: Visit 2 (Month 2)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  59. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3

    Time frame: Visit 3 (Month 4)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  60. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4

    Time frame: Visit 4 (Month 6)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  61. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5

    Time frame: Visit 5 (Month 9)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  62. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6

    Time frame: Visit 6 (Month 12)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  63. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7

    Time frame: Visit 7 (Month 15)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  64. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8

    Time frame: Visit 8 (Month 18)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  65. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9

    Time frame: Visit 9 (Month 21)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  66. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10

    Time frame: Visit 10 (Month 24)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  67. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11

    Time frame: Visit 11 (Month 27)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  68. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12

    Time frame: Visit 12 (Month 30)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  69. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13

    Time frame: Visit 13 (Month 33)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  70. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14

    Time frame: Visit 14 (Month 36)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  71. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15

    Time frame: Visit 15 (Month 39)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  72. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16

    Time frame: Visit 16 (Month 42)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  73. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17

    Time frame: Visit 17 (Month 45)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  74. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18

    Time frame: Visit 18 (Month 48)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  75. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19

    Time frame: Visit 19 (Month 51)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  76. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20

    Time frame: Visit 20 (Month 54)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  77. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21

    Time frame: Visit 21 (Month 57)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  78. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22

    Time frame: Visit 22 (Month 60)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  79. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23

    Time frame: Visit 23 (Month 63)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  80. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24

    Time frame: Visit 24 (Month 66)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  81. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25

    Time frame: Visit 25 (Month 69)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  82. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26

    Time frame: Visit 26 (Month 72)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  83. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27

    Time frame: Visit 27 (Month 75)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  84. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28

    Time frame: Visit 28 (Month 78)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  85. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29

    Time frame: Visit 29 (Month 81)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  86. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30

    Time frame: Visit 30 (Month 84)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  87. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31

    Time frame: Visit 31 (Month 87)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  88. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit

    Time frame: Withdrawal visit (up to Month 90)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

  89. Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit

    Time frame: Final visit (up to Month 90)

    Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Important dates

Study start
1998
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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