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Trial record 92 of 146 for:    epilepsy AND Bethesda

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01339559
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 767 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 11, 2011
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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 Name: UCB34714

Primary Outcome Measures :
  1. Occurrence of at least one Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ]
  2. Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ]
  3. Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ]

Secondary Outcome Measures :
  1. Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ]
    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.

  2. 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) ]
    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).

  3. 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). ]
    A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01339559

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Sponsors and Collaborators
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Study Director: UCB Cares +1 844 599 2273 (UCB)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: UCB BIOSCIENCES, Inc. Identifier: NCT01339559     History of Changes
Other Study ID Numbers: N01379
2010-020345-27 ( EudraCT Number )
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Partial Onset Seizures
Adjunctive treatment
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases