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

June 13, 2018 updated by: UCB Pharma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bethune, France
      • Lille, France
      • Saint Brieuc, France
      • Toulouse, France
  • Germany
      • Berlin, Germany
      • Bernau, Germany
      • Bielefeld, Germany
      • Munchen, Germany
      • Munster, Germany
      • Ulm, Germany
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Kecskemet, Hungary
      • Szeged, Hungary
  • Italy
      • Bergamo, Italy
      • Firenze, Italy
      • Germaneto, Italy
      • Messina, Italy
      • Perugia, Italy
      • Pisa, Italy
      • Torino, Italy
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Zaragoza, Spain
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Garden Grove, California, United States
      • Loma Linda, California, United States
      • Newport Beach, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • Stanford, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Fort Collins, Colorado, United States
    • Connecticut
      • Danbury, Connecticut, United States
      • New Haven, Connecticut, United States
      • Waterbury, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Danville, Indiana, United States
      • Elkhart, Indiana, United States
    • Maryland
      • Waldorf, Maryland, United States
    • Michigan
      • Grand Rapids, Michigan, United States
    • Missouri
      • Columbia, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Flushing, New York, United States
      • Schenectady, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Oberlin, Ohio, United States
      • Westerville, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Texas
      • Austin, Texas, United States
      • Bedford, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Layton, Utah, United States
      • Ogden, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Bluefield, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Marshfield, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivaracetam (BRV) 1
50 mg daily
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 Names:
  • 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 Names:
  • ucb 34714
Experimental: Brivaracetam (BRV) 2
100 mg daily
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 Names:
  • 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 Names:
  • ucb 34714

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01306
  • RPCE07F1216
  • 2008-000145-58 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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