EUCTR2010-018766-23-LTActive, not recruitingNot 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. - n/a
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 57
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
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. - NAMedDRA version: 12.1Level: LLTClassification code 10015037Term: EpilepsyepilepsyEUCTR2010-018766-23-ATovartis Pharma Services AG115
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. - NAMedDRA version: 12.1Level: LLTClassification code 10015037Term: EpilepsyepilepsyEUCTR2010-018766-23-EEovartis Pharma Services AG57
Active, not recruiting
Phase 1
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. - NAepilepsyEUCTR2010-018766-23-BEovartis Pharma Services AG57
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. - n/aepilepsyEUCTR2010-018766-23-LVovartis Pharma Services AG57
Not yet recruiting
Not Applicable
A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild OsteoarthritisKCT0004925The Catholic University of Korea, Uijeongbu St. Mary’s Hospital100