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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01339559
First received: April 19, 2011
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Brivaracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Occurrence of at least one Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
    28 day adjusted seizure frequency will be 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.

  • Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
    Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). Negative changes from Baseline indicate an improvement (ie, a reduction).

  • Responder rate in POS (type I) frequency over the Evaluation Period [ Time Frame: Baseline Period: Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). ] [ Designated as safety issue: No ]
    A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.


Estimated Enrollment: 820
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: UCB34714

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339559

  Hide Study Locations
Locations
United States, Arizona
001
Phoenix, Arizona, United States
013
Phoenix, Arizona, United States
006
Tucson, Arizona, United States
United States, Arkansas
775
Little Rock, Arkansas, United States
United States, California
025
San Francisco, California, United States
United States, Colorado
060
Aurora, Colorado, United States
United States, Florida
071
Miami, Florida, United States
027
Orlando, Florida, United States
064
Port Charlotte, Florida, United States
044
Sarasota, Florida, United States
United States, Georgia
023
Atlanta, Georgia, United States
062
Columbus, Georgia, United States
048
Rome, Georgia, United States
United States, Idaho
039
Boise, Idaho, United States
United States, Illinois
029
Chicago, Illinois, United States
005
Peoria, Illinois, United States
017
Winfield, Illinois, United States
United States, Iowa
020
Ames, Iowa, United States
069
Iowa City, Iowa, United States
United States, Kentucky
780
Lexington, Kentucky, United States
United States, Maryland
008
Bethesda, Maryland, United States
068
Waldorf, Maryland, United States
United States, Michigan
055
East Lansing, Michigan, United States
United States, Minnesota
009
Golden Valley, Minnesota, United States
United States, Montana
051
Missoula, Montana, United States
United States, New Hampshire
032
Lebanon, New Hampshire, United States
United States, New Jersey
042
Hamilton, New Jersey, United States
United States, New York
022
New York, New York, United States
099
New York, New York, United States
098
Poughkeepsie, New York, United States
United States, North Carolina
010
Asheville, North Carolina, United States
003
Durham, North Carolina, United States
United States, Ohio
034
Cleveland, Ohio, United States
070
Columbus, Ohio, United States
778
Columbus, Ohio, United States
002
Toledo, Ohio, United States
United States, Oklahoma
043
Oklahoma City, Oklahoma, United States
091
Oklahoma City, Oklahoma, United States
054
Tulsa, Oklahoma, United States
United States, Pennsylvania
015
Philadelphia, Pennsylvania, United States
United States, South Carolina
028
Charleston, South Carolina, United States
021
Port Royal, South Carolina, United States
United States, Tennessee
776
Nashville, Tennessee, United States
United States, Texas
050
Arlington, Texas, United States
061
Austin, Texas, United States
777
Dallas, Texas, United States
011
Dallas, Texas, United States
035
Dallas, Texas, United States
049
Houston, Texas, United States
United States, Virginia
036
Charlottesville, Virginia, United States
United States, Washington
056
Spokane, Washington, United States
United States, Wisconsin
052
Madison, Wisconsin, United States
057
Milwaukee, Wisconsin, United States
Austria
202
Inssbruck, Austria
201
Linz, Austria
203
Wien, Austria
Belgium
226
Hechtel-Eksel, Belgium
227
Leuven, Belgium
Brazil
104
Belo Horizonte, Brazil
100
Florianopolis, Brazil
101
Sao Paulo, Brazil
Bulgaria
294
Bagoevrad, Bulgaria
286
Sofiya, Bulgaria
287
Sofiya, Bulgaria
Canada, Alberta
075
Calgary, Alberta, Canada
Canada, Ontario
078
London, Ontario, Canada
076
Toronto, Ontario, Canada
Canada, Quebec
077
Greenfield Park, Quebec, Canada
Canada, Saskatchewan
080
Saskatoon, Saskatchewan, Canada
Canada
079
Montreal, Canada
Czech Republic
917
Brno, Czech Republic
916
Kromeriz, Czech Republic
251
Ostrava, Czech Republic
256
Ostrava, Czech Republic
913
Ostrava Poruba, Czech Republic
252
Praha 1, Czech Republic
253
Praha 4, Czech Republic
250
Zlin, Czech Republic
Estonia
650
Tallinn, Estonia
652
Tallinn, Estonia
651
Tartu, Estonia
Finland
275
Kuopio, Finland
278
Oulu, Finland
276
Tampere, Finland
277
Turku, Finland
France
301
Bethune, France
305
Montpellier, France
Germany
329
Berlin, Germany
326
Bernau, Germany
332
Bielefeld, Germany
902
Erlangen, Germany
331
Goettingen, Germany
327
Kiel, Germany
900
Marburg, Germany
335
Muenchen, Germany
334
Osnabruck, Germany
330
Ravensburg, Germany
328
Ulm, Germany
Hong Kong
701
Hong Kong, Hong Kong
700
Hong Kong, Hong Kong
Hungary
410
Budapest, Hungary
412
Budapest, Hungary
411
Budapest, Hungary
414
Hajdu-Bihar, Hungary
413
Szekszard, Hungary
India
731
Nashik, Maharashtra, India
726
Bangalore, India
727
Hyderbad, India
729
Madurai, India
728
Maharashtra, India
725
Mumbai, India
Italy
378
Bari, Italy
380
Firenze, Italy
379
Milano, Italy
377
Monserrato, Italy
386
Napoli, Italy
376
Perugia, Italy
375
Pisa, Italy
383
Pozzilli, Italy
384
Reggio Calabria, Italy
Japan
855
Hiroshima, Japan
852
Itami-city, Japan
850
Osaka, Japan
851
Shizuoka, Japan
854
Yokohama-City, Japan
Korea, Republic of
753
Busan, Korea, Republic of
752
Gwangju, Korea, Republic of
750
Seoul, Korea, Republic of
751
Seoul, Korea, Republic of
754
Seoul, Korea, Republic of
Latvia
627
Daugavpils, Latvia
629
Jekabpils, Latvia
628
Riga, Latvia
625
Valmiera, Latvia
Lithuania
425
Alytus, Lithuania
427
Kaunas, Lithuania
426
Vilnius, Lithuania
Mexico
128
Guadalajara, Jalisco, Mexico
126
Guadalajara, Jalisco, Mexico
129
Aguascalientes, Mexico
127
Culiacan, Mexico
125
Distrito Federal, Mexico
130
Mexico D.F., Mexico
Netherlands
401
Heemstede, Netherlands
400
Heeze, Netherlands
403
Zwolle, Netherlands
Poland
475
Bialystok, Poland
485
Gdansk, Poland
791
Gdansk, Poland
481
Katowice, Poland
480
Katowice, Poland
795
Katowice, Poland
478
Katowice, Poland
793
Krakow, Poland
476
Krakow, Poland
483
Lublin, Poland
479
Poznan, Poland
477
Poznan, Poland
482
Poznan, Poland
794
Warszawa, Poland
488
Warszawa, Poland
Puerto Rico
038
San Juan, Puerto Rico
Russian Federation
501
Kazan, Russian Federation
506
Kazan, Russian Federation
502
Moscow, Russian Federation
503
Moscow, Russian Federation
509
Nizhny Novgorod, Russian Federation
508
Smolensk, Russian Federation
Spain
529
Barcelona, Spain
540
Barcelona, Spain
535
Barcelona, Spain
528
Barcelona, Spain
532
La Coruna, Spain
539
San Sebastian, Spain
527
Valencia, Spain
537
Valencia, Spain
526
Valladolid, Spain
Sweden
551
Goteborg, Sweden
552
Linkoping, Sweden
550
Stockholm, Sweden
Taiwan
806
Kaohsiung City, Taiwan
801
Taichung, Taiwan
800
Tainan, Taiwan
803
Taoyuan Hsien, Taiwan
United Kingdom
602
Morriston, Swansea, United Kingdom
603
Birmingham, United Kingdom
606
Cardiff, United Kingdom
601
Cornwall, United Kingdom
600
London, United Kingdom
605
Middlesborough, United Kingdom
607
Newcastle, United Kingdom
608
Salford, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01339559     History of Changes
Other Study ID Numbers: N01379, 2010-020345-27
Study First Received: April 19, 2011
Last Updated: October 16, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Canada: Health Canada
Estonia: The State Agency of Medicine
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Czech Republic: State Institute for Drug Control
Finland: Ministry of Social Affairs and Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: Ministry of Health, Social and Family Affairs
India: Central Drugs Standard Control Organization
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health and Consumption
Sweden: The National Board of Health and Welfare
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Epilepsy
Brivaracetam
Partial Onset Seizures
Adjunctive treatment

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014