A Study of Brivaracetam in Subjects With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175929
First received: September 9, 2005
Last updated: April 10, 2015
Last verified: April 2015
  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 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

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:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Responder rate in partial onset seizures (type I) over the 7-week Maintenance period [ Time Frame: During the Maintenance period (approximately 7 weeks) ] [ Designated as safety issue: No ]
    A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.

  • Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period [ Time Frame: During the Maintenance period (approximately 7 weeks) ] [ Designated as safety issue: No ]
    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%.

  • Percentage of seizure-free subjects over the 7-week Maintenance period [ Time Frame: During the Maintenance period (approximately 7 weeks) ] [ Designated as safety issue: No ]
  • Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods [ Time Frame: Baseline through Maintenance period (approximately 11 weeks) ] [ Designated as safety issue: No ]
  • Time to N-th seizure in the Maintenance period [ Time Frame: During the Maintenance period (approximately 7 weeks) ] [ Designated as safety issue: No ]

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: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175929     History of Changes
Other Study ID Numbers: N01114, 2004-001856-35
Study First Received: September 9, 2005
Last Updated: April 10, 2015
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:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 01, 2015