EUCTR2010-018766-23-AT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- epilepsy
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 115
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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
Outcomes
Primary Outcomes
Not specified
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