A Study of Brivaracetam in Subjects With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175929
First received: September 9, 2005
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Epilepsy, Focal
Other: Placebo
Drug: Brivaracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam as Adjunctive Treatment at Doses of 50 and 150 mg/Day in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Partial onset seizure frequency (Type I) per week over the 7-week maintenance period [ Time Frame: 7-week maintenance period ] [ Designated as safety issue: No ]
    Partial onset seizure frequency (Type I) per week over the 7-week maintenance period


Secondary Outcome Measures:
  • Percentage change from Baseline to the 7-week maintenance period in seizure frequency per week for partial onset seizures (Type I) [ Time Frame: Baseline to 7-week maintenance period ] [ Designated as safety issue: No ]
    Percentage change from Baseline to the 7-week maintenance period in seizure frequency per week for partial onset seizures (Type I)

  • 50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week maintenance period [ Time Frame: 7-week maintenance period ] [ Designated as safety issue: No ]
    50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week maintenance period

  • Percentage of seizure-free subjects (all seizure types) over the 10-week treatment period [ Time Frame: 10-week treatment period ] [ Designated as safety issue: No ]
    Percentage of seizure-free subjects (all seizure types) over the 10-week treatment period


Enrollment: 157
Study Start Date: May 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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)
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 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175929

  Show 57 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00175929     History of Changes
Other Study ID Numbers: N01114, EudraCT 2004-001856-35
Study First Received: September 9, 2005
Last Updated: June 29, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Spain: Ministry of Health and Consumption
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Epilepsy
Focal Epilepsy
Partial Onset Seizures
Brivaracetam

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014