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Trial record 1 of 1 for:    NCT01339559
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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.
 
ClinicalTrials.gov Identifier: NCT01339559
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : June 4, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

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
Allocation: N/A
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. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01339559


Locations
Show Show 184 study locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Study Protocol  [PDF] May 15, 2015
Statistical Analysis Plan  [PDF] January 28, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT01339559    
Other Study ID Numbers: N01379
2010-020345-27 ( EudraCT Number )
First Posted: April 20, 2011    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Epilepsy
Brivaracetam
Partial Onset Seizures
Adjunctive treatment
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brivaracetam
Anticonvulsants