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Completed

NCT Number: NCT01339559

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

202, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES, Inc.

Industry

Registry information

Official study 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

Acronym: BRITE™

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2011
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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