A Study of Brivaracetam in Subjects With Partial Onset Seizures

April 10, 2015 updated by: UCB Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Duffel, Belgium
      • Edegem, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Czech Republic
      • Beroun, Czech Republic
      • Brno, Czech Republic
      • Ceske Budejovice, Czech Republic
      • Praha 1, Czech Republic
      • Praha 5, Czech Republic
  • Finland
      • Kuopio, Finland
      • Oys (Oulu), Finland
      • Tampere, Finland
  • France
      • Angers Cedex 1, France
      • Bethune, France
      • Dijon, France
      • Grenoble Cedex 9, France
      • Lille, France
      • Lyon, France
      • Marseille, France
      • Montpellier Cedex 5, France
      • Nancy, France
      • Paris, France
      • Rennes, France
      • Strasbourg, France
      • Tain L'Hermitage, France
      • Toulouse Cedex 04, France
  • Germany
      • Berlin, Germany
      • Bielefeld, Germany
      • Bonn, Germany
      • Chemnitz, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Kehl, Germany
      • Munchen, Germany
      • Ulm, Germany
  • Netherlands
      • Heemstede, Netherlands
      • Heeze, Netherlands
  • Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Spain
      • Madrid, Spain
      • Valencia, Spain
      • Vigo, Spain
  • United Kingdom
      • Bucks, United Kingdom
      • Cambridge, United Kingdom
      • Cardiff, United Kingdom
      • Glasgow, United Kingdom
      • Hartshill, United Kingdom
      • Liverpool, United Kingdom
      • Newcastle, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Drug: Brivaracetam
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)
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
Placebo Comparator: Placebo
Matching placebo tablets administered twice a day
Other: Placebo
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)
Experimental: Brivaracetam 150 mg/day
Brivaracetam 150 mg/day, 75 mg administered twice a day
Drug: Brivaracetam
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)
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7-week maintenance period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the Maintenance period (approximately 7 weeks)
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)
During the Maintenance period (approximately 7 weeks)
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)
During the Maintenance period (approximately 7 weeks)
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.
During the Maintenance period (approximately 7 weeks)
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%.
During the Maintenance period (approximately 7 weeks)
Percentage of seizure-free subjects over the 7-week Maintenance period
Time Frame: During the Maintenance period (approximately 7 weeks)
During the Maintenance period (approximately 7 weeks)
Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods
Time Frame: Baseline through Maintenance period (approximately 11 weeks)
Baseline through Maintenance period (approximately 11 weeks)
Time to N-th seizure in the Maintenance period
Time Frame: During the Maintenance period (approximately 7 weeks)
During the Maintenance period (approximately 7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01114
  • 2004-001856-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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