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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175825
First received: September 9, 2005
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Epilepsy
Other: Placebo
Drug: Brivaracetam
Drug: Brivaracetam 20 mg/day
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 5, 20 and 50 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 1) per week over the 7-week Treatment Period [ Time Frame: Baseline to 7-week Treatment Period ] [ Designated as safety issue: No ]
    Partial onset seizure frequency (Type 1) per week over the 7-week Treatment Period


Secondary Outcome Measures:
  • Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1) [ Time Frame: Baseline to the 7-week Treatment Period ] [ Designated as safety issue: No ]
    Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1)

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

  • Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period. [ Time Frame: 7-week Treatment Period ] [ Designated as safety issue: No ]
    Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period.


Enrollment: 210
Study Start Date: November 2005
Study Completion Date: June 2006
Primary Completion Date: June 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 7-week Treatment Period
Experimental: Brivaracetam 5 mg/day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg/day in a double-blinded way for the 7-week Treatment period
Experimental: Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Drug: Brivaracetam 20 mg/day
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg/day in a double-blinded way for the 7-week Treatment 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 7-week Treatment period

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175825

  Show 42 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

Responsible Party: Study Director, UCB, Inc.
ClinicalTrials.gov Identifier: NCT00175825     History of Changes
Other Study ID Numbers: N01193
Study First Received: September 9, 2005
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
Mexico: Ministry of Health
India: Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy: partial onset seizures
brivaracetam

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

ClinicalTrials.gov processed this record on April 16, 2014