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Completed

NCT Number: NCT00615615

Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–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

  • diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
  • epilepsy was classifiable according to the ILAE Classification
  • >= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
  • unsatisfactory current AED treatment in terms of efficacy and/or safety
  • stable AED treatment consisting of no more than two AEDs

Exclusion criteria

  • treatable seizure etiology
  • epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
  • history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
  • history of or the presence of pseudo seizures
  • current diagnosis of Lennox-Gastaut syndrome

Treatment and study plan

Levetiracetam

Drug
  • high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
  • low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less

Placebo

Drug

Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Primary outcomes

  1. Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period

    Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

    Calculated as 7-day partial onset seizure frequency.

Secondary outcomes

  1. 50% responder rate in seizure frequency per week during the Treatment Period

    Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

    Response rate is defined as percent of patients experiencing at least a 50% reduction from baseline in the seizure frequency per week during the Treatment Period.

  2. Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period

    Time frame: From Baseline to the 14-weeks Treatment period

    Categories as follows: <-25%, -25% to <25%, 25% to <50%, 50% to <75%, 75% to <100%, and 100%

  3. Change from baseline in the average duration of seizure free intervals

    Time frame: From Baseline to the 14-weeks Treatment period

    Intervals are defined as seizure-free if no seizures are reported.

  4. Number of seizure free days during the Treatment Period

    Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

    A day is regarded as seizure-free if no seizures are reported.

  5. Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period

    Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)

    Absolute change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  6. Absolute change from baseline in partial onset seizure frequency per week during the Titration Period

    Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)

    Absolute change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  7. Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period

    Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)

    Absolute change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  8. Percent change from baseline in partial onset seizure frequency per week during the Treatment Period

    Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)

    Percent change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  9. Percent change from baseline in partial onset seizure frequency per week during the Titration Period

    Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)

    Percent change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  10. Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period

    Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)

    Percent change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period.

    A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

  11. Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period

    Time frame: Beginning of the Evaluation Period (Week 14)

    A subject was regarded as seizure-free if not seizures were reported since the beginning of the Evaluation Period.

  12. Partial onset seizure frequency per week during the Titration Period

    Time frame: During the 6-weeks Titration period (Week 8 to Week 14)

    Calculated as 7-day partial onset seizure frequency.

  13. Partial onset seizure frequency per week during the Evaluation Period

    Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)

    Calculated as 7-day partial onset seizure frequency.

  14. Total seizure frequency per week (Types I + II + III) during the Treatment Period

    Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

    Calculated as 7-day partial onset seizure frequency.

  15. Total seizure frequency per week (Types I + II + III) during the Titration Period

    Time frame: During the 6-weeks Titration period (Week 8 to Week 14)

    Calculated as 7-day partial onset seizure frequency.

  16. Total seizure frequency per week (Types I + II + III) during the Evaluation Period

    Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)

    Calculated as 7-day partial onset seizure frequency.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
Feb 14, 2008
Registry last updated
Jul 30, 2020

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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