a 12-week, randomized, double-blind, placebo-controlled exploratory dose-titration study to assess the antiepileptic activity of BGG492 given orally three times daily (TID) as adjunctive treatment in patients with refractory partial onset seizures. - NA

• Conditions: epilepsy; MedDRA version: 12.1Level: LLTClassification code 10015037Term: Epilepsy

• Registration Number: EUCTR2010-018766-23-EE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

- male♀ outpatients age 18 to 65 years
- weight sup or equal to 50 kg
- have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures
- must have at least 4 partial seizures during the 4-week baseline period and the 4 weeks immediately preceding the baseline period
- have no 28-day seizure-free period during the 8 weeks preceding randomization
- must have a positive test result for iGluR3 antibodies in the blood at screening
- must have uncontrolled partial seizures despite having been treated with at least two different anti-epileptic drugs within the last 2 years prior to screening
- must have received stable treatment with 1 or a max of 2 AED....
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any of the following seizure conditions:
- presence of only non-motor simple partial seizures
- history of psychogenic seizure
- abscences, myoclonic seizures
- previous history of Lennox-Gastaut syndrome
- history of status epilepticus or seizure clusters
- only seizures caused by an underlying medical illness during the 52 weeks prior to randomization.
2. Have been treated with Vangabatrin, MAO inhibitors, Barbiturates, intermittent Benzodiazepines, L-dopa formulations, concomitant use of potential inhibitors of OATP transporters
....

Study & Design

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