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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT00150800
• Date of registration: 06/09/2005
• Prospective Registration: Yes
• Primary sponsor: UCB PHARMA Inc. (US)
• Public title: 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
• Scientific 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
• Date of first enrolment: January 2006
• Target sample size: 668
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00150800
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, India, Mexico, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam

Primary Outcome(s)

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)]

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)]

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)]

Secondary Outcome(s)

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)]

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)]

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)]

Secondary ID(s)

N01199

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00150800