Back to resultsA 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
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Brivaracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy; Monotherapy, Partial Onset Seizures, Adults and Adolescents
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Brivaracetam (BRV) 1
Brivaracetam (BRV) 2
Arm Description
50 mg daily
100 mg daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00699283
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy; Monotherapy, Partial Onset Seizures, Adults and Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brivaracetam (BRV) 1
Arm Type
Experimental
Arm Description
50 mg daily
Arm Title
Brivaracetam (BRV) 2
Arm Type
Experimental
Arm Description
100 mg daily
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
ucb 34714
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
ucb 34714
Intervention Description
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)
Primary Outcome Measure Information:
Title
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
Description
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.
Time Frame
From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Loma Linda
State/Province
California
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United States
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Newport Beach
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California
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United States
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Riverside
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California
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United States
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Sacramento
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California
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United States
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Stanford
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California
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United States
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Denver
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Colorado
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United States
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Fort Collins
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Colorado
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United States
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Danbury
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Connecticut
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United States
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New Haven
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Connecticut
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United States
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Waterbury
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Connecticut
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United States
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Gainesville
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Florida
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United States
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Miami
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Florida
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United States
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Atlanta
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Georgia
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United States
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Honolulu
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Hawaii
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Chicago
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Illinois
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United States
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Danville
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Indiana
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United States
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Elkhart
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Indiana
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United States
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Waldorf
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Maryland
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United States
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Grand Rapids
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Michigan
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United States
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Columbia
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Missouri
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United States
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Lebanon
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New Hampshire
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United States
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Albuquerque
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New Mexico
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United States
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Flushing
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New York
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United States
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Schenectady
State/Province
New York
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United States
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Charlotte
State/Province
North Carolina
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United States
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Oberlin
State/Province
Ohio
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United States
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Westerville
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Ohio
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United States
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Tulsa
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Oklahoma
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United States
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Bethlehem
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Pennsylvania
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United States
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Jenkintown
State/Province
Pennsylvania
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United States
City
Providence
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Rhode Island
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United States
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Austin
State/Province
Texas
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United States
City
Bedford
State/Province
Texas
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United States
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San Antonio
State/Province
Texas
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United States
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Layton
State/Province
Utah
Country
United States
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Ogden
State/Province
Utah
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United States
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Burlington
State/Province
Vermont
Country
United States
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Bluefield
State/Province
Virginia
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United States
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Seattle
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Washington
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United States
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Morgantown
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West Virginia
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United States
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Marshfield
State/Province
Wisconsin
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United States
City
Bethune
Country
France
City
Lille
Country
France
City
Saint Brieuc
Country
France
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Toulouse
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France
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Berlin
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Germany
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Bernau
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Germany
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Bielefeld
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Germany
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Munchen
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Germany
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Munster
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Germany
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Ulm
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Germany
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Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemet
Country
Hungary
City
Szeged
Country
Hungary
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Bergamo
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Italy
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Firenze
Country
Italy
City
Germaneto
Country
Italy
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Messina
Country
Italy
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Perugia
Country
Italy
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Pisa
Country
Italy
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Torino
Country
Italy
City
Barcelona
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Spain
City
Madrid
Country
Spain
City
Murcia
Country
Spain
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29486396
Citation
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.
Results Reference
result
Learn more about this trial
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
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