Clinical trials: Intractable Epilepsy
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
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.
Epilepsy
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
- Trial name
- NCT02170064
- Testing
- BIA 2-093 (Eslicarbazepine acetate)
- Where
- Romania
- Volunteers
- 35 people
- Sponsor
- Bial - Portela C S.A.
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 Epilepsy
Thalidomide Low Threshold in Epilepsy
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
- Trial name
- NCT01061866
- Testing
- 3-phthalimidoglutarimide (Thalidomide)
- Volunteers
- 7 people
- Sponsor
- National Institute of Neurology and Neurosurgery, Mexico
Epilepsies, Partial
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
The investigators will treat patients with fully characterized refractory unifocal neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the…
- Trial name
- NCT01745952
- Testing
- figure-of-eight active rTMS coil, round active rTMS coil
- Where
- Belgium
- Volunteers
- 11 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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.
Inherited Mitochondrial Disease
A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease
The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical…
- Trial name
- NCT05218655
- Testing
- Vatiquinone
- Where
- 26 sites in United States, France and 5 more
- Volunteers
- 101 people
- Sponsor
- PTC Therapeutics
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
P-glycoprotein Inhibition as Adjunct Treatment for Medically Refractory Epilepsy.
In up to 1 out of 3 patients with epilepsy, seizures continue to occur despite the use of one or more antiepileptic medications.
- Trial name
- NCT00524134
- Testing
- Carvedilol-CR
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Columbia University
Refractory Infantile Spasms
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.
- Trial name
- NCT03976076
- Testing
- JBPOS0101
- Where
- 23 sites in United States, South Korea
- Volunteers
- 16 people
- Sponsor
- Bio-Pharm Solutions Co., Ltd.
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
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.
Spasms, Infantile
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS.
- Trial name
- NCT02551731
- Testing
- Cannabidiol Oral Solution
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- INSYS Therapeutics 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
Epilepsy
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic…
- Trial name
- NCT00334958
- Testing
- Rufinamide
- Where
- 77 sites in United States
- Volunteers
- 356 people
- Sponsor
- Eisai Inc.
Refractory Partial Onset Seizures
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301.
- Trial name
- NCT00448539
- Testing
- Rufinamide
- Where
- 27 sites in United States
- Volunteers
- 286 people
- Sponsor
- Eisai Inc.
Epilepsy
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
- Trial name
- NCT00368069
- Testing
- Keppra® extended release formulation - XR
- Where
- 34 sites in Brazil, Finland and 5 more
- Volunteers
- 158 people
- Sponsor
- UCB Pharma
Refractory Epilepsy
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective…
- Trial name
- NCT06141668
- Testing
- Neurostimulation
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital