Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)

August 16, 2021 updated by: UCB BIOSCIENCES, Inc.

An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Study Type

Interventional

Enrollment (Actual)

767

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

  • Austria
      • Innsbruck, Austria
        • 202
      • Linz, Austria
        • 201
      • Wien, Austria
        • 203
  • Belgium
      • Hechtel-Eksel, Belgium
        • 226
      • Leuven, Belgium
        • 227
  • Brazil
      • Belo Horizonte, Brazil
        • 104
      • Florianopolis, Brazil
        • 100
      • Sao Paulo, Brazil
        • 101
  • Bulgaria
      • Blagoevgrad, Bulgaria
        • 294
      • Sofia, Bulgaria
        • 286
      • Sofia, Bulgaria
        • 287
  • Canada
      • Montreal, Canada
        • 079
    • Alberta
      • Calgary, Alberta, Canada
        • 075
    • Ontario
      • London, Ontario, Canada
        • 078
      • Toronto, Ontario, Canada
        • 076
    • Quebec
      • Greenfield Park, Quebec, Canada
        • 077
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 080
  • Czechia
      • Brno, Czechia
        • 917
      • Kromeriz, Czechia
        • 916
      • Ostrava, Czechia
        • 251
      • Ostrava, Czechia
        • 256
      • Ostrava Poruba, Czechia
        • 913
      • Praha 1, Czechia
        • 252
      • Praha 4, Czechia
        • 253
      • Zlin, Czechia
        • 250
  • Estonia
      • Tallinn, Estonia
        • 650
      • Tallinn, Estonia
        • 652
      • Tartu, Estonia
        • 651
  • Finland
      • Kuopio, Finland
        • 275
      • Tampere, Finland
        • 276
  • France
      • Bethune, France
        • 301
      • Montpellier, France
        • 305
  • Germany
      • Berlin, Germany
        • 329
      • Bernau, Germany
        • 326
      • Bielefeld, Germany
        • 332
      • Erlangen, Germany
        • 902
      • Göttingen, Germany
        • 331
      • Kiel, Germany
        • 327
      • Marburg, Germany
        • 900
      • Muenchen, Germany
        • 335
      • Osnabruck, Germany
        • 334
      • Ravensburg, Germany
        • 330
      • Ulm, Germany
        • 328
  • Hong Kong
      • Hong Kong, Hong Kong
        • 701
      • Hong Kong, Hong Kong
        • 700
  • Hungary
      • Budapest, Hungary
        • 410
      • Budapest, Hungary
        • 411
      • Budapest, Hungary
        • 412
      • Hajdú-Bihar, Hungary
        • 414
      • Szekszard, Hungary
        • 413
  • India
      • Bangalore, India
        • 726
      • Hyderabad, India
        • 727
      • Madurai, India
        • 729
      • Mumbai, India
        • 725
      • Mumbai, India
        • 728
    • Maharashtra
      • Nashik, Maharashtra, India
        • 731
  • Italy
      • Bari, Italy
        • 378
      • Firenze, Italy
        • 380
      • Milano, Italy
        • 379
      • Monserrato, Italy
        • 377
      • Napoli, Italy
        • 386
      • Perugia, Italy
        • 376
      • Pisa, Italy
        • 375
      • Pozzilli, Italy
        • 383
      • Reggio Calabria, Italy
        • 384
  • Japan
      • Hiroshima, Japan
        • 855
      • Osaka, Japan
        • 850
      • Shizuoka, Japan
        • 851
      • Yokohama-City, Japan
        • 854
    • Hyogo
      • Itami, Hyogo, Japan
        • 852
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 753
      • Seoul, Korea, Republic of
        • 750
      • Seoul, Korea, Republic of
        • 751
      • Seoul, Korea, Republic of
        • 754
  • Latvia
      • Daugavpils, Latvia
        • 627
      • Jekabpils, Latvia
        • 629
      • Riga, Latvia
        • 628
      • Valmiera, Latvia
        • 625
  • Lithuania
      • Alytus, Lithuania
        • 425
      • Kaunas, Lithuania
        • 427
      • Vilnius, Lithuania
        • 426
  • Mexico
      • Aguascalientes, Mexico
        • 129
      • Culiacan, Mexico
        • 127
      • Distrito Federal, Mexico
        • 125
      • Mexico City, Mexico
        • 130
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • 126
      • Guadalajara, Jalisco, Mexico
        • 128
  • Netherlands
      • Heemstede, Netherlands
        • 401
      • Heeze, Netherlands
        • 400
      • Zwolle, Netherlands
        • 403
  • Poland
      • Bialystok, Poland
        • 475
      • Gdansk, Poland
        • 485
      • Gdansk, Poland
        • 791
      • Katowice, Poland
        • 795
      • Katowice, Poland
        • 478
      • Katowice, Poland
        • 480
      • Katowice, Poland
        • 481
      • Krakow, Poland
        • 476
      • Krakow, Poland
        • 793
      • Lublin, Poland
        • 483
      • Poznan, Poland
        • 479
      • Poznan, Poland
        • 477
      • Poznan, Poland
        • 482
      • Warszawa, Poland
        • 794
      • Warszawa, Poland
        • 488
  • Puerto Rico
      • San Juan, Puerto Rico
        • 038
  • Russian Federation
      • Kazan, Russian Federation
        • 501
      • Kazan, Russian Federation
        • 506
      • Moscow, Russian Federation
        • 502
      • Moscow, Russian Federation
        • 503
      • Nizhny Novgorod, Russian Federation
        • 509
      • Smolensk, Russian Federation
        • 508
  • Spain
      • Barcelona, Spain
        • 528
      • Barcelona, Spain
        • 529
      • Barcelona, Spain
        • 535
      • Barcelona, Spain
        • 540
      • San Sebastian, Spain
        • 539
      • Santiago de Compostela, Spain
        • 532
      • Valencia, Spain
        • 527
      • Valencia, Spain
        • 537
      • Valladolid, Spain
        • 526
  • Sweden
      • Goteborg, Sweden
        • 551
      • Linkoping, Sweden
        • 552
      • Stockholm, Sweden
        • 550
  • Taiwan
      • Kaohsiung City, Taiwan
        • 806
      • Taichung, Taiwan
        • 801
      • Tainan, Taiwan
        • 800
      • Taoyuan, Taiwan
        • 803
  • United Kingdom
      • Birmingham, United Kingdom
        • 603
      • London, United Kingdom
        • 600
      • Middlesborough, United Kingdom
        • 605
      • Newcastle, United Kingdom
        • 607
      • Salford, United Kingdom
        • 608
      • Truro, United Kingdom
        • 601
    • Swansea
      • Morriston, Swansea, United Kingdom
        • 602
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • 001
      • Phoenix, Arizona, United States, 85006
        • 013
      • Tucson, Arizona, United States, 85718
        • 006
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • 775
    • California
      • San Francisco, California, United States, 94115
        • 025
    • Colorado
      • Aurora, Colorado, United States, 80045
        • 060
    • Florida
      • Miami, Florida, United States, 33176
        • 071
      • Orlando, Florida, United States, 32819
        • 027
      • Port Charlotte, Florida, United States, 33952
        • 064
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • 023
      • Rome, Georgia, United States, 30165
        • 048
    • Idaho
      • Boise, Idaho, United States, 83702
        • 039
    • Illinois
      • Chicago, Illinois, United States, 60612
        • 029
      • Peoria, Illinois, United States, 61637
        • 005
      • Winfield, Illinois, United States, 60190
        • 017
    • Iowa
      • Ames, Iowa, United States, 50010
        • 020
      • Iowa City, Iowa, United States, 52242
        • 069
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • 780
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • 008
      • Waldorf, Maryland, United States, 20603
        • 068
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • 009
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • 032
    • New Jersey
      • Hamilton, New Jersey, United States, 08619
        • 042
    • New York
      • New York, New York, United States, 10011
        • 099
      • New York, New York, United States, 10016
        • 022
      • Poughkeepsie, New York, United States, 12601
        • 098
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • 010
      • Durham, North Carolina, United States, 27705
        • 003
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • 034
      • Columbus, Ohio, United States, 43210
        • 778
      • Columbus, Ohio, United States, 43215
        • 070
      • Toledo, Ohio, United States, 43614
        • 002
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • 043
      • Oklahoma City, Oklahoma, United States, 73112
        • 091
      • Tulsa, Oklahoma, United States, 74136-83
        • 054
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • 015
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • 028
      • Port Royal, South Carolina, United States, 29965
        • 021
    • Tennessee
      • Nashville, Tennessee, United States, 37232-25
        • 776
    • Texas
      • Austin, Texas, United States, 78758
        • 061
      • Dallas, Texas, United States, 75251
        • 011
      • Dallas, Texas, United States, 75251
        • 777
      • Dallas, Texas, United States, 75390
        • 035
      • Houston, Texas, United States, 77025
        • 049
      • Mansfield, Texas, United States, 76063
        • 050
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • 036
    • Washington
      • Spokane, Washington, United States, 99204
        • 056
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • 052
      • Milwaukee, Wisconsin, United States, 53215
        • 057

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject completed the Treatment Period of N01358 or the evaluation period of N01258
  • Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
  • Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
  • Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria:

  • Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
  • Severe medical, neurological, or 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 BRV study
  • Planned participation in any other clinical study of another investigational drug or device during this study
  • Pregnant or lactating woman
  • Any medical condition which, in the Investigator's opinion, warrants exclusion
  • Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivaracetam
Brivaracetam with a maximum of 200 mg/day
Drug: Brivaracetam

Tablet, Flexible dosing up to 200 mg/day, twice daily.

The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Other Names:
  • UCB34714

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)
Time Frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
Time Frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Time Frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
From Entry Visit (Month 0) until the Last Visit (up to 84 months)

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 until the Last Visit (up to 84 months)
The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
From Baseline of the previous study until the Last Visit (up to 84 months)
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 until the Last Visit (up to 84 months)

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.

Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
From Baseline of the previous study until the Last Visit (up to 84 months)
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
Time Frame: From Baseline of the previous study until the Last Visit (up to 84 months)

A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.

Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.
From Baseline of the previous study until the Last Visit (up to 84 months)

Collaborators and Investigators

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

Sponsor

UCB BIOSCIENCES, Inc.

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 (Actual)

May 11, 2011

Primary Completion (Actual)

April 18, 2019

Study Completion (Actual)

April 18, 2019

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

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

  • N01379
  • 2010-020345-27 (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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