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A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

This study has been terminated.
(An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00698581
First received: June 12, 2008
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy


Condition Intervention Phase
Epilepsy
 Drug: Brivaracetam
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The cumulative exit rate at 112 days after the beginning of the Baseline Antiepileptic Drug (AED) tapering phase. [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BRV 1
50mg/day
 Drug: Brivaracetam
25mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50mg > 20mg) for subjects not participating in the follow-up study)
Other Name: ucb 34714
Experimental: BRV 2
100mg/day
 Drug: Brivaracetam
25mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100mg > 50mg > 20mg) for subjects not participating in the follow-up study)
Other Name: ucb 34714

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects from 16 to 75 years, both inclusive
  • Well-characterized focal epilepsy or epileptic syndrome.
  • Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period.
  • Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose.

Exclusion Criteria:

  • Seizure type IA non-motor as only seizure type.
  • History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline.
  • Other serious uncontrolled disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698581

  Show 71 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: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00698581     History of Changes
Other Study ID Numbers: N01276, RPCE07F1214
Study First Received: June 12, 2008
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by UCB, Inc.:
Epilepsy; Monotherapy
Partial Onset Seizures
Adults and Adolescents

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 May 19, 2013