An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761774

N01315

2008-001433-98 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Brivaracetam

Experimental group

Description:

Brivaracetam at flexible dosing up to 200mg /day

Treatment:

Drug: Brivaracetam