Skip to main content
OpenTrials
Completed

NCT Number: NCT00150800

This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Completed

Looking for future studies?

Notify Me

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

N01199 1420, Chatswood, New South Wales, Australia

Loading trial locations.

About this study

Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

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 and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
  • Subjects with epilepsy who have participated in previous brivaracetam trials 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
  • Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
  • Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

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 the visit schedule or medication intake in the previous brivaracetam study
  • Pregnant or lactating women
  • Participation in any clinical study of another investigational drug or device during the study

Treatment and study plan

Brivaracetam

Drug
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 10 mg and 25 mg
  • Route of Administration: Oral

Primary outcomes

  1. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period

    Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

    Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  2. Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period

    Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

    Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  3. Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period

    Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

    A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.

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 to the Evaluation Period (up to 11 years)

    Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

    A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied 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 to the Evaluation Period (up to 11 years)

    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.

  3. Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period

    Time frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)

    A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.

Sponsors and collaborators

Lead sponsor

UCB PHARMA Inc. (US)

Industry

Registry information

Official study title

An Open-label, Multi-center, 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
2006
Primary completion
2017
Study completion
2017
First posted
Sep 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.