Clinical trials: Seizure, Refractory
Tuberous Sclerosis Complex-associated Refractory Seizures
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures.
- Trial name
- EXIST-3 (NCT01713946)
- Testing
- RAD001, Antiepileptic drug (1 to 3 only), open label RAD001 (only used for post-extension phase)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 366 people
- Sponsor
- Novartis Pharmaceuticals
Epilepsy
Feasibility Study on LITT for Medical Refractory Epilepsy
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial…
- Trial name
- NCT02820740
- Testing
- NeuroBlate System
- Where
- 5 sites in United States
- Volunteers
- 4 people
- Sponsor
- Monteris Medical
Epilepsy
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of…
- Trial name
- NCT00735397
- Testing
- perampanel
- Where
- 239 sites in United States, Argentina and 37 more
- Volunteers
- 1,218 people
- Sponsor
- Eisai Inc.
Epilepsies, Partial
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
- Trial name
- PROSPER1 (NCT00772603)
- Testing
- 2400mg SPN-804, 1200mg SPN-804
- Where
- 71 sites in United States, Bulgaria and 6 more
- Volunteers
- 366 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Epilepsy
Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients…
- Trial name
- NCT00416195
- Testing
- E2007
- Where
- 2 sites in Latvia
- Volunteers
- 48 people
- Sponsor
- Eisai Co., Ltd.
Mitochondrial Diseases, Drug Resistant Epilepsy
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase.
- Conditions
- Mitochondrial Diseases, Drug Resistant Epilepsy, Leigh Disease, Leigh Syndrome
- Trial name
- MIT-E (NCT04378075)
- Testing
- Vatiquinone
- Where
- 27 sites in United States, Canada and 7 more
- Volunteers
- 68 people
- Sponsor
- PTC Therapeutics
Refractory Partial Epilepsy
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration, 12 weeks maintenance, and 4…
- Trial name
- NCT00957684
- Testing
- eslicarbazepine acetate
- Where
- Portugal
- Volunteers
- 402 people
- Sponsor
- Bial - Portela C S.A.
Partial Epilepsy
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy
The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a…
- Trial name
- NCT00957372
- Testing
- eslicarbazepine acetate, ESL - Open-label Extension (Part II)
- Where
- Portugal
- Volunteers
- 253 people
- Sponsor
- Bial - Portela C S.A.
Partial-onset Seizures
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures
- Trial name
- NCT01618695
- Testing
- Perampanel
- Where
- 117 sites in Australia, China and 5 more
- Volunteers
- 940 people
- Sponsor
- Eisai Co., Ltd.
Epilepsy
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs).
- Trial name
- NCT01118455
- Testing
- Vagus Nerve Stimulation (VNS) Therapy, Anti-Epileptic Drug (AED)
- Where
- 19 sites in Austria, Belgium and 3 more
- Volunteers
- 134 people
- Sponsor
- Cyberonics, Inc.
Refractory Partial Seizures
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs).
- Trial name
- NCT00849212
- Testing
- E2007
- Where
- 9 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Eisai Co., Ltd.
Partial Epilepsy in Children and Adolescents
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by…
- Trial name
- NCT00988156
- Testing
- Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate
- Where
- 91 sites in Austria, Bosnia and Herzegovina and 19 more
- Volunteers
- 304 people
- Sponsor
- Bial - Portela C S.A.
Epilepsy
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.
- Trial name
- NCT02170077
- Testing
- BIA 2-093
- Where
- Portugal
- Volunteers
- 144 people
- Sponsor
- Bial - Portela C S.A.
Epilepsy
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
- Trial name
- NCT00292461
- Testing
- Zonisamide, Lamotrigine
- Where
- 8 sites in China
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Epilepsy, Partial
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152451
- Testing
- Seletracetam (ucb 44212)
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- UCB S.A. - Pharma Sector
Seizures
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three…
- Trial name
- RESTORE1 (NCT00232596)
- Testing
- Retigabine
- Where
- 54 sites in United States, Argentina and 3 more
- Volunteers
- 306 people
- Sponsor
- GlaxoSmithKline
Refractory Partial Seizures
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00700310
- Testing
- perampanel
- Where
- 137 sites in Australia, Bulgaria and 21 more
- Volunteers
- 712 people
- Sponsor
- Eisai Inc.
Epilepsy
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric participants…
- Trial name
- NCT02914314
- Testing
- perampanel
- Where
- 18 sites in United States, Latvia
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Super-refractory Status Epilepticus
Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).
- Trial name
- SRSE (NCT02052739)
- Testing
- SAGE-547
- Where
- 17 sites in United States
- Volunteers
- 25 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Refractory Epilepsy
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy.
- Trial name
- NCT02474407
- Testing
- diazepam nasal spray, diazepam rectal gel
- Where
- 22 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acorda Therapeutics