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NCT Number: NCT00175916

Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

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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

509, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
  • Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
  • Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study
  • Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected

Exclusion criteria

  • Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
  • Poor compliance with visit schedule or medication intake in previous brivaracetam study
  • Participation in any clinical study of another investigational drug or device during the study
  • Pregnant or lactating woman

Treatment and study plan

Brivaracetam (ucb 34714)

Drug

10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry 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; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.

Primary outcomes

  1. Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: From Entry Visit until Last Visit (up to 162 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 an Adverse Event (AE)

    Time frame: From Entry Visit until Last Visit (up to 162 months)

    An AE is any untoward medical occurrence in a participant or trial participant 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 until Last Visit (up to 162 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 an 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 Entry Visit until Last Visit (up to 162 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.

    Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

  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 Entry Visit until Last Visit (up to 162 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.

    Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

  3. Responder Rate in POS (Type I) Frequency Over the Evaluation Period

    Time frame: From Entry Visit until Last Visit (up to 162 months)

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

    Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

Important dates

Study start
2005
Primary completion
2019
Study completion
2019
First posted
Sep 15, 2005
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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