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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150800

N01199

Details and patient eligibility

About

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.

Full description

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

Enrollment: 668 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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668 participants in 1 patient group

Brivaracetam

Experimental group

Description:

Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.

Treatment:

Drug: Brivaracetam