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Completed

NCT Number: NCT00152451

Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

N01191 108, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
  • Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
  • Subjects who have been treated for epilepsy for >=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
  • Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion criteria

  • Seizures occurring in clusters.
  • Status epilepticus within 6 months of Visit 1
  • History of non-epileptic seizures
  • Subjects on vigabatrin
  • Subjects on felbamate, unless treatment has been continuous for >2 years
  • Ongoing psychiatric disease other than mild controlled disorders.
  • Subjects with clinically significant organ dysfunction
  • Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
  • Pregnant or lactating women
  • Subjects currently taking levetiracetam (LEV)
  • Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs)

Treatment and study plan

Seletracetam (ucb 44212)

Drug
  • Pharmaceutical form: oral capsules
  • Concentration: 10 and 50 mg
  • Route of administration: oral administration

Primary outcomes

  1. Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period

    Time frame: During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.

    The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

Secondary outcomes

  1. Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)

    Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.

    The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

  2. Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period

    Time frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.

    The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  3. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)

    Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.

    The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

  4. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period

    Time frame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.

    The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

  5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period

    Time frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.

    The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  6. Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period

    Time frame: During the Treatment Period (Week 5 to Week 15)

    Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

  7. Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period

    Time frame: During the Treatment Period (Week 5 to Week 15)

    Calculated as 7-day partial onset seizure (type I) frequency. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).

  8. Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period

    Time frame: During the Up-Titration Period (Week 5 to Week 12)

    Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

  9. Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period

    Time frame: During the Down-Titration Period (Week 13 to Week 15)

    Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  10. Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period

    Time frame: During the Treatment Period (Week 5 to Week 15)

    Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

  11. Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period

    Time frame: During the Treatment Period (Week 5 to Week 15)

    Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).

  12. Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period

    Time frame: During the Up-Titration Period (Week 5 to Week 12)

    Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

  13. Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period

    Time frame: During the Down-Titration Period (Week 13 to Week 15)

    Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  14. Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period

    Time frame: Week 12, compared to Baseline Period (Week 1 to Week 4)

    A responder was defined as a subject with a >= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.

  15. Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period

    Time frame: Week 12, compared to Baseline Period (Week 1 to Week 4)

    Categories of percentage change in seizures from Baseline were as following: < -25%; -25% to <25%; 25% to <75%; 75% to <100%; 100%.

  16. Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period

    Time frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)

    A day was considered seizure-free, if no seizure was reported during 24 hours.

  17. Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period

    Time frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  18. Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period

    Time frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

  19. Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period

    Time frame: Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).

  20. Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period

    Time frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).

  21. Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)

    Time frame: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).

  22. Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)

    Time frame: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)

    Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).

Sponsors and collaborators

Lead sponsor

UCB S.A. - Pharma Sector

Industry

Registry information

Official study title

An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Mar 29, 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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