A Study of Brivaracetam in Subjects With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
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 Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by UCB Pharma

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 Pharma:
Epilepsy
Focal Epilepsy
Partial Onset Seizures
Brivaracetam

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

ClinicalTrials.gov processed this record on September 22, 2014