Trial record 1 of 2 for:    N01379
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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

April 19, 2011
October 16, 2014
April 2011
June 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Occurrence of at least one treatment-emergent adverse event during the Evaluation Period (approximately 4 years ) [ Time Frame: From entry Visit 1 through end of treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of discontinuations due to a treatment-emergent adverse event during the Evaluation period (approximately 4 years) [ Time Frame: From entry Visit 1 through end of treatment (up to approximately 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of at least one treatment-emergent, drug-related adverse event during the Evaluation period (approximately 4 years) [ Time Frame: From entry Visit 1 through end of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01339559 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage change from Baseline in Type I seizure frequency per 28 days over the Evaluation period (up to approximately 4 years). [ 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. 28-day type I seizure frequency is the total number of type I seizures divided by the total number of days evaluated multiplied by 28; negative changes from Baseline indicate an improvement (ie., a reduction)
  • Percentage change from Baseline in type I+II+III (all types combined) seizure frequency per 28 days over the Evaluation period (approximately 4 years) [ 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. 28-day type I+II+III seizure frequency is the total number of type I+II+III seizures divided by the total number of days evaluated multiplied by 28; negative changes from Baseline indicate an improvement (ie., a reduction)
Not Provided
Not Provided
 
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
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).

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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
Experimental: Brivaracetam
Brivaracetam with a maximum of 200 mg/day
Intervention: Drug: Brivaracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
820
July 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico,   Canada,   Brazil,   Mexico,   Austria,   Belgium,   Czech Republic,   Finland,   Bulgaria,   France,   Germany,   Italy,   Netherlands,   Hungary,   Lithuania,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom,   Latvia,   Estonia,   Hong Kong,   India,   Korea, Republic of,   Taiwan,   Japan
 
NCT01339559
N01379, 2010-020345-27
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP