This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

August 16, 2021 updated by: UCB PHARMA Inc. (US)

An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

Study Type

Interventional

Enrollment (Actual)

668

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
      • Fitzroy, Australia
        • N01199 1422
    • New South Wales
      • Chatswood, New South Wales, Australia
        • N01199 1420
      • Randwick, New South Wales, Australia
        • N01199 1430
    • South Australia
      • Adelaide, South Australia, Australia
        • N01199 1423
      • Woodville, South Australia, Australia
        • N01199 1428
    • Victoria
      • Clayton, Victoria, Australia
        • N01199 1427
      • Parkville, Victoria, Australia
        • N01199 1426
      • West Heidelberg, Victoria, Australia
        • N01199 1421
  • Brazil
      • Campinas, Brazil
        • N01199 1028
      • Curitiba, Brazil
        • N01199 1325
      • Florianopolis, Brazil
        • N01199 1024
      • Florianópolis, Brazil
        • N01199 1150
      • Porto Alegre, Brazil
        • N01199 1331
      • Porto Alegre, Brazil
        • N01199 1332
      • Riberao Preto, Brazil
        • N01199 1022
      • Salvador, Brazil
        • N01199 1023
      • Sao Paulo, Brazil
        • N01199 1021
      • Sao Paulo, Brazil
        • N01199 1027
      • Sao Paulo, Brazil
        • N01199 1030
      • Sao Paulo, Brazil
        • N01199 1326
      • São José do Rio Preto, Brazil
        • N01199 1029
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • N01199 1316
    • Quebec
      • Greenfield Park, Quebec, Canada
        • N01199 1312
      • Montreal, Quebec, Canada
        • N01199 1311
      • Montreal, Quebec, Canada
        • N01199 1314
      • Quebec City, Quebec, Canada
        • N01199 1313
  • India
      • Bangalore, India
        • N01199 1045
      • Bangalore, India
        • N01199 1256
      • Bangalore, India
        • N01199 1257
      • Bangalore, India
        • N01199 1261
      • Chennai, India
        • N01199 1046
      • Hyderabad, India
        • N01199 1042
      • Hyderabad, India
        • N01199 1253
      • Hyderabad, India
        • N01199 1262
      • Jaipur, India
        • N01199 1258
      • Lucknow, India
        • N01199 1040
      • Lucknow, India
        • N01199 1250
      • Mumbai, India
        • N01199 1043
      • Mumbai, India
        • N01199 1259
      • Parel Mumbai, India
        • N01199 1265
      • Pune, India
        • N01199 1251
      • Pune Maharashtra, India
        • N01199 1264
      • Tirupati, India
        • N01199 1263
    • Maharashti
      • Mumbai, Maharashti, India
        • N01199 1266
  • Mexico
      • Aguascalientes, Mexico
        • N01199 1010
      • Chihuahua, Mexico
        • N01199 1008
      • Chihuahua, Mexico
        • N01199 1009
      • Guadalajara, Mexico
        • N01199 1003
      • Mexico City, Mexico
        • N01199 1403
      • Monterrey, Mexico
        • N01199 1005
      • Monterrey, Mexico
        • N01199 1007
      • San Luis Potosi, Mexico
        • N01199 1002
      • Zapopan, Mexico
        • N01199 1001
    • Nuevo Leon
      • San Nicholas De Los Garza, Nuevo Leon, Mexico
        • N01199 1412
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • N01199 1051
      • Phoenix, Arizona, United States
        • N01199 1362
      • Tucson, Arizona, United States
        • N01199 1374
    • Arkansas
      • Little Rock, Arkansas, United States
        • N01199 1050
    • California
      • Fresno, California, United States
        • N01199 1078
      • Newport Beach, California, United States
        • N01199 1392
      • San Francisco, California, United States
        • N01199 1087
      • San Francisco, California, United States
        • N01199 1368
    • Georgia
      • Atlanta, Georgia, United States
        • N01199 1396
      • Augusta, Georgia, United States
        • N01199 1385
    • Illinois
      • Chicago, Illinois, United States
        • N01199 1356
      • Springfield, Illinois, United States
        • N01199 1388
    • Kansas
      • Wichita, Kansas, United States
        • N01199 1375
    • Kentucky
      • Lexington, Kentucky, United States
        • N01199 1364
      • Louisville, Kentucky, United States
        • N01199 1380
      • Paducah, Kentucky, United States
        • N01199 1052
    • Louisiana
      • Ruston, Louisiana, United States
        • N01199 1083
    • Maryland
      • Baltimore, Maryland, United States
        • N01199 1373
      • Bethesda, Maryland, United States
        • N01199 1086
    • Massachusetts
      • Burlington, Massachusetts, United States
        • N01199 1077
    • Michigan
      • Detroit, Michigan, United States
        • N01199 1391
      • Detroit, Michigan, United States
        • N01199 1395
      • Grand Rapids, Michigan, United States
        • N01199 1071
    • Minnesota
      • Saint Paul, Minnesota, United States
        • N01199 1389
    • Mississippi
      • Tupelo, Mississippi, United States
        • N01199 1079
    • Missouri
      • Chesterfield, Missouri, United States
        • N01199 1360
      • Saint Louis, Missouri, United States
        • N01199 1352
    • Montana
      • Great Falls, Montana, United States
        • N01199 1069
    • New Jersey
      • Toms River, New Jersey, United States
        • N01199 1062
    • New York
      • New York, New York, United States
        • N01199 1053
      • Rochester, New York, United States
        • N01199 1365
    • Ohio
      • Cincinnati, Ohio, United States
        • N01199 1366
      • Columbus, Ohio, United States
        • N01199 1054
    • Oregon
      • Portland, Oregon, United States
        • N01199 1359
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • N01199 1055
      • Philadelphia, Pennsylvania, United States
        • N01199 1059
    • South Carolina
      • Greenville, South Carolina, United States
        • N01199 1081
    • Tennessee
      • Nashville, Tennessee, United States
        • N01199 1061
    • Texas
      • Dallas, Texas, United States
        • N01199 1084
      • Dallas, Texas, United States
        • N01199 1394
      • Houston, Texas, United States
        • N01199 1064
    • Utah
      • Salt Lake City, Utah, United States
        • N01199 1082
    • Virginia
      • Charlottesville, Virginia, United States
        • N01199 1367
      • Richmond, Virginia, United States
        • N01199 1393
    • Washington
      • Seattle, Washington, United States
        • N01199 1376
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • N01199 1369

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:

  • Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
  • Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
  • Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
  • Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
  • Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

Exclusion Criteria:

  • Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
  • Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
  • Pregnant or lactating women
  • Participation in any clinical study of another investigational drug or device during the study

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 used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
Drug: Brivaracetam
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 10 mg and 25 mg
  • Route of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)

Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)

The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:

(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.
From Baseline of the previous study to the Evaluation Period (up to 11 years)

Collaborators and Investigators

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

Sponsor

UCB PHARMA Inc. (US)

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

January 1, 2006

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 8, 2005

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01199

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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