An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

June 13, 2018 updated by: UCB Pharma

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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

  • Australia
    • New South Wales
      • Chatswood, New South Wales, Australia
        • 400
    • South Australia
      • Adelaide, South Australia, Australia
        • 404
    • Victoria
      • Fitzroy, Victoria, Australia
        • 402
      • Parkville, Victoria, Australia
        • 401
  • Belgium
      • Gent, Belgium
        • 004
      • Kortrijk, Belgium
        • 003
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 205
      • Edmonton, Alberta, Canada
        • 203
    • Ontario
      • Toronto, Ontario, Canada
        • 206
  • Czechia
      • Brno, Czechia
        • 023
      • Litomysl, Czechia
        • 020
      • Ostava, Czechia
        • 021
      • Ostrava-Trebovice, Czechia
        • 024
      • Praha 4, Czechia
        • 026
  • France
      • Bethune, France
        • 040
      • Toulouse Cedex 09, France
        • 041
  • Germany
      • Berlin, Germany
        • 055
      • Bernau, Germany
        • 056
      • Bielefeld, Germany
        • 054
      • Mainz, Germany
        • 063
      • Munchen, Germany
        • 051
      • Regensburg, Germany
        • 065
  • Hungary
      • Budapest, Hungary
        • 072
      • Budapest, Hungary
        • 074
  • Italy
      • Bergamo, Italy
        • 084
      • Messina, Italy
        • 082
      • Orbassano, Italy
        • 085
      • Perugia, Italy
        • 083
      • Pisa, Italy
        • 080
  • Spain
      • Madrid, Spain
        • 090
  • Sweden
      • Goteborg, Sweden
        • 100
      • Lund, Sweden
        • 102
      • Stockholm, Sweden
        • 101
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • 304
    • California
      • Fresno, California, United States
        • 281
      • Pasadena, California, United States
        • 288
      • Riverside, California, United States
        • 240
      • Sacramento, California, United States
        • 245
    • Illinois
      • Peoria, Illinois, United States
        • 285
    • Indiana
      • Indianapolis, Indiana, United States
        • 224
    • Kentucky
      • Lexington, Kentucky, United States
        • 266
    • Maryland
      • Waldorf, Maryland, United States
        • 231
    • Massachusetts
      • Burlington, Massachusetts, United States
        • 278
    • New York
      • New York, New York, United States
        • 270
    • North Carolina
      • Hickory, North Carolina, United States
        • 284
    • Ohio
      • Columbus, Ohio, United States
        • 241
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 265
    • Tennessee
      • Germantown, Tennessee, United States
        • 297
    • Texas
      • Austin, Texas, United States
        • 260
      • Bedford, Texas, United States
        • 236
      • Dallas, Texas, United States
        • 267
      • Houston, Texas, United States
        • 268
    • Utah
      • Layton, Utah, United States
        • 211
      • Ogden, Utah, United States
        • 235
    • Vermont
      • Burlington, Vermont, United States
        • 218
    • Virginia
      • Danville, Virginia, United States
        • 279
    • West Virginia
      • Charleston, West Virginia, United States
        • 277
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • 213

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 and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
  • Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.

Exclusion Criteria:

• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Brivaracetam
Brivaracetam at flexible dosing up to 200mg /day
Drug: Brivaracetam
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
Other Names:
  • ucb 34714

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
During the Evaluation Period (up to 9 years)
Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
During the Evaluation Period (up to 9 years)
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
During the Evaluation Period (up to 9 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
During the Evaluation Period (up to 9 years)
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
During the Evaluation Period (up to 9 years)
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
Time Frame: During the Evaluation Period (up to 9 years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
During the Evaluation Period (up to 9 years)

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

Helpful Links

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

November 1, 2008

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (ESTIMATE)

September 30, 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

  • N01315
  • 2008-001433-98 (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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