Study Stopped
An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.
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
2 other identifiers
interventional
88
7 countries
53
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2008
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
April 13, 2016
CompletedJuly 11, 2018
March 1, 2018
1.4 years
June 12, 2008
March 14, 2016
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
From Week 1 up to Week 17
Secondary Outcomes (3)
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Baseline through Re-conversion (approximately 31 weeks)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Baseline through Re-conversion (approximately 31 weeks)
Study Arms (2)
Brivaracetam 50 mg
EXPERIMENTAL50 mg/day
Brivaracetam 100 mg
EXPERIMENTAL100 mg/day
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (53)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Fresno, California, United States
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Pasadena, California, United States
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Denver, Colorado, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Conyers, Georgia, United States
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Macon, Georgia, United States
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Peoria, Illinois, United States
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Lexington, Kentucky, United States
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Burlington, Massachusetts, United States
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Las Vegas, Nevada, United States
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Summit, New Jersey, United States
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Mineola, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Hickory, North Carolina, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Germantown, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Danville, Virginia, United States
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Charleston, West Virginia, United States
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Waukesha, Wisconsin, United States
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Chatswood, New South Wales, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Parkville, Victoria, Australia
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West Heidelberg, Victoria, Australia
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Ghent, Belgium
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Kortrijk, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Sakaskatoon, Saskatchewan, Canada
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Brno, Czechia
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Litomyšl, Czechia
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Ostava, Czechia
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Ostrava-Trebovice, Czechia
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Prague, Czechia
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Praha-4, Czechia
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Aschaffenburg, Germany
Unknown Facility
Halle, Germany
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Mainz, Germany
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Regensburg, Germany
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Gothenburg, Sweden
Unknown Facility
Lund, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Uppsala, Sweden
Related Publications (1)
Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
PMID: 29486396RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Cares
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 17, 2008
Study Start
August 1, 2008
Primary Completion
January 1, 2010
Study Completion
February 1, 2010
Last Updated
July 11, 2018
Results First Posted
April 13, 2016
Record last verified: 2018-03