A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Stopped early · Phase 3

Conditions studied: Epilepsy

In brief

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Key facts

Study ID

NCT00698581

Run by

UCB Pharma

People needed

88

Starts

2008-08-01

Expected to finish

2010-02-01

Last updated by the study team

2018-07-11

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects from 16 to 75 years, both inclusive
• Well-characterized focal epilepsy or epileptic syndrome
• Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
• Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose

You may not qualify if…

• Seizure type IA non-motor as only seizure type
• History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
• Other serious uncontrolled disease

Where it is running

• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Danville, Virginia, United States
• Study site — Charleston, West Virginia, United States
• Study site — Waukesha, Wisconsin, United States
• Study site — Chatswood, New South Wales, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Clayton, Victoria, Australia
• Study site — Fitzroy, Victoria, Australia
• Study site — Parkville, Victoria, Australia
• Study site — West Heidelberg, Victoria, Australia
• Study site — Ghent, Belgium
• Study site — Kortrijk, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Windsor, Ontario, Canada
• Study site — Sakaskatoon, Saskatchewan, Canada
• Study site — Brno, Czechia
• Study site — Litomyšl, Czechia
• Study site — Ostava, Czechia
• Study site — Ostrava-Trebovice, Czechia
• Study site — Prague, Czechia
• Study site — Praha-4, Czechia
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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