Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Pharma
ClinicalTrials.gov Identifier:
NCT00699283
First received: June 12, 2008
Last updated: August 26, 2014
Last verified: September 2012

June 12, 2008
August 26, 2014
August 2008
March 2010   (final data collection date for primary outcome measure)
The primary efficacy analysis variable is the Cumulative Exit Rate at 112 days after the beginning of the Baseline Antiepileptic Drug (AED) tapering phase [ Time Frame: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks) ] [ Designated as safety issue: No ]
The Cumulative Exit Rate of subjects who have exited the study at 16 weeks or 112 days after the beginning of the Baseline AED tapering phase (at Visit 4) will be compared to the historical lower bound estimate of the 80% prediction interval (computed assuming a sample size of 50 subjects) of the cumulative rate of subjects who have exited the study. This lower bound historical estimate is computed to be 0.74.
The primary efficacy analysis variable is the cumulative exit rate at 112 days after the beginning of the baseline AED tapering phase. [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00699283 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.

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 BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Epilepsy
  • Drug: Brivaracetam
    25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
    Other Name: ucb 34714
  • Drug: Brivaracetam
    25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
    Other Name: ucb 34714
  • Experimental: Brivaracetam (BRV) 1
    50 mg daily
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam (BRV) 2
    100 mg daily
    Intervention: Drug: Brivaracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
62
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
16 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Hungary,   Italy,   Spain
 
NCT00699283
N01306, RPCE07F1216, 2008-000145-58
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP