Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment brivaracetam
Phase phase 3
Sponsor UCB Pharma
Start date November 2008
End date October 2016
Trial size 108 participants
Trial identifier NCT00761774, 2008-001433-98, N01315

Summary

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Brivaracetam at flexible dosing up to 200mg /day
brivaracetam ucb 34714
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.

Primary Outcomes

Measure
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)
Withdrawal due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)
Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)

Secondary Outcomes

Measure
Percentage of subjects on continuous Brivaracetam monotherapy for at least 3 months of the Evaluation Period (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)
Percentage of subjects on continuous Brivaracetam monotherapy for at least 6 months, of the Evaluation Period (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)
Percentage of subjects on continuous Brivaracetam monotherapy for at least 12 months of the Evaluation Period (up to 9 years)
time frame: During the Evaluation Period (up to 9 years)

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial. - Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected. Exclusion Criteria: • Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

Additional Information

Official title An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.