Skip to main content
OpenTrials
Completed

NCT Number: NCT00175825

A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florianópolis, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/female from 16 to 65 years
  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • History of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
  • Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion criteria

  • Seizure type IA non-motor as only seizure type
  • Seizures occurring only in clusters
  • Status epilepticus during the last 2 years before Visit 1
  • 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 7-week Treatment Period

Brivaracetam

Drug

Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

Other names: Briviact

Primary outcomes

  1. Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period

    Time frame: During the 7-week Treatment Period

    Calculated as 7-day partial onset seizure frequency.

Secondary outcomes

  1. Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period

    Time frame: Baseline, during the 7-week Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, 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 seizure frequency from Baseline.

  2. Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.

  3. Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

    Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

  4. Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

  5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, 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 seizure frequency from Baseline.

  6. Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

    A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.

  7. Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period

    Time frame: During the 7-week Treatment Period

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

  8. Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period

    Time frame: During the 7-week Treatment Period

    A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.

  9. Number of Seizure-free Days Per 4 Weeks

    Time frame: Baseline, during the 7-week Treatment Period

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

  10. Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period

    Time frame: During the 7-week Treatment Period

    Number of days to first, fifth, and tenth seizure after baseline.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 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
Oct 2, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.