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Completed

NCT Number: NCT00175929

A Study of Brivaracetam in Subjects With Partial Onset Seizures

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

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Key information

Conditions

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

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • Subjects with a history of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
  • Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
  • Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion criteria

  • Seizure type IA non-motor as only seizure type
  • History or presence of seizures occurring only in clustered patterns
  • History of cerebrovascular accident (CVA)
  • Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Treatment and study plan

Placebo

Other

Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Brivaracetam

Drug

Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Primary outcomes

  1. Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

    Time frame: 7-week maintenance period

    Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

Secondary outcomes

  1. Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

  2. Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

  3. Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

  4. Responder rate in partial onset seizures (type I) over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

    A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.

  5. Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

    The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to ≤ 100%, and 100%.

  6. Percentage of seizure-free subjects over the 7-week Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

  7. Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods

    Time frame: Baseline through Maintenance period (approximately 11 weeks)

  8. Time to N-th seizure in the Maintenance period

    Time frame: During the Maintenance period (approximately 7 weeks)

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Apr 13, 2015

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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