Clinical trials: Seizure, Refractory
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
Epilepsy
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
- Trial name
- NCT00175825
- Testing
- Brivaracetam
- Where
- 42 sites in United States, Brazil and 2 more
- Volunteers
- 210 people
- Sponsor
- UCB Pharma
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
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.
Epilepsy, Partial
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152503
- Testing
- Seletracetam (UCB44212)
- Where
- 17 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- UCB Pharma SA
Refractory Partial Seizures
Evaluating the 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 safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00699972
- Testing
- E2007 (perampanel)
- Where
- 97 sites in United States, Argentina and 4 more
- Volunteers
- 390 people
- Sponsor
- Eisai Inc.
Status Epilepticus
Treatment of Refractory Status Epilepticus
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
- Trial name
- NCT00265616
- Testing
- propofol, thiopental/pentobarbital
- Where
- 5 sites in United States, Switzerland
- Volunteers
- 23 people
- Sponsor
- Brigham and Women's Hospital
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.
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.
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.
CDKL5 Deficiency Disorder
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
- Trial name
- Marigold (NCT03572933)
- Testing
- ganaxolone
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 101 people
- Sponsor
- Marinus Pharmaceuticals
Partial Epilepsy
Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy…
- Trial name
- NCT00957047
- Testing
- eslicarbazepine acetate, ESL - Part II
- Where
- Portugal
- Volunteers
- 395 people
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
- Trial name
- NCT01142193
- Testing
- USL255
- Where
- 69 sites in United States, Argentina and 14 more
- Volunteers
- 249 people
- Sponsor
- Upsher-Smith Laboratories
Seizures
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to…
- Trial name
- RESTORE2 (NCT00235755)
- Testing
- Retigabine
- Where
- 70 sites in United States, Australia and 11 more
- Volunteers
- 539 people
- Sponsor
- GlaxoSmithKline
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
Seizures, Epilepsies, Partial
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures.
- Conditions
- Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy, Generalized
- Trial name
- NCT00319501
- Testing
- Vanquix Auto-Injector (Diazepam Injection)
- Where
- 86 sites in United States
- Volunteers
- 234 people
- Sponsor
- Pfizer
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
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-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.
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.