A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not available

• Conditions: Epilepsy Partial onset seizures; MedDRA version: 12.1Level: LLTClassification code 10065336Term: Partial epilepsy

• Registration Number: EUCTR2010-021448-17-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-11
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Have completed 10 week double-blind treatment evaluation Phase plus one week of dose-tapering in study 2207 or 2211, have cooperated in study procedures and have been perceived by investigator as deriving benefit from taking the study medication without experiencing tolerability issues.
- patients who wish to continue BGG492 treatment
- male and female outpatients age 18 to 66 Years (inclusive)
- weight sup or equal to 45kg
- are currently treated with a stable dose of 1 or max 2 licensed AEDs
- are reliable
- have provided written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- history of status epilepticus or seizure clusters occuring during study 2207 or 2211
- patients with a planned brain surgery in the next 6 months
- no physical examination changes suggestive of progressive neurological changes (AD, PD, MS)
- patients who received prohibited medication or used benzodiazepines intermittently during the double-blind studies
- history of hypersensitivity to study drug or to drugs of similar chemical classes
- etc....

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified