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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

Primary Purpose

Epilepsy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Brivaracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy; Monotherapy, Partial Onset Seizures, Adults and Adolescents

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 50 mg

Brivaracetam 100 mg

Arm Description

50 mg/day

100 mg/day

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

The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study

Full Information

First Posted
June 12, 2008
Last Updated
June 13, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00698581
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
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

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 Brivaracetam (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
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam 50 mg
Arm Type
Experimental
Arm Description
50 mg/day
Arm Title
Brivaracetam 100 mg
Arm Type
Experimental
Arm Description
100 mg/day
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 Week 1 up to Week 17
Secondary Outcome Measure Information:
Title
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Time Frame
Baseline through Re-conversion (approximately 31 weeks)
Title
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Time Frame
Baseline through Re-conversion (approximately 31 weeks)
Title
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Time Frame
Baseline through Re-conversion (approximately 31 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
Phoenix
State/Province
Arizona
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Conyers
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Burlington
State/Province
Massachusetts
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Summit
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Danville
State/Province
Virginia
Country
United States
City
Charleston
State/Province
West Virginia
Country
United States
City
Waukesha
State/Province
Wisconsin
Country
United States
City
Chatswood
State/Province
New South Wales
Country
Australia
City
Adelaide
State/Province
South Australia
Country
Australia
City
Clayton
State/Province
Victoria
Country
Australia
City
Fitzroy
State/Province
Victoria
Country
Australia
City
Parkville
State/Province
Victoria
Country
Australia
City
West Heidelberg
State/Province
Victoria
Country
Australia
City
Gent
Country
Belgium
City
Kortrijk
Country
Belgium
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Sakaskatoon
State/Province
Saskatchewan
Country
Canada
City
Brno
Country
Czechia
City
Litomysl
Country
Czechia
City
Ostava
Country
Czechia
City
Ostrava-Trebovice
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha-4
Country
Czechia
City
Aschaffenburg
Country
Germany
City
Halle (Saale)
Country
Germany
City
Mainz
Country
Germany
City
Regensburg
Country
Germany
City
Goteborg
Country
Sweden
City
Lund
Country
Sweden
City
Stockholm
Country
Sweden
City
Uppsala
Country
Sweden

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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