Clinical trials: Drug-Resistant Epilepsy
Epilepsy
PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing…
- Trial name
- PuLsE 2 (NCT01281280)
- Where
- 18 sites in Belgium, Canada and 5 more
- Volunteers
- 81 people
- Sponsor
- Cyberonics, Inc.
Drug Resistant Epilepsy
Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy
This is a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study with cross-over to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients with Drug Resistant Epilepsy
- Trial name
- NCT04714996
- Testing
- ES-481, Open-Label Extension Study
- Where
- 4 sites in Australia
- Volunteers
- 24 people
- Sponsor
- ES Therapeutics Australia Pty Ltd
Drug Resistant Partial Onset Seizure
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
- Trial name
- NCT01963208
- Testing
- ganaxolone
- Where
- 71 sites in United States, Australia and 4 more
- Volunteers
- 405 people
- Sponsor
- Marinus Pharmaceuticals
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, 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
Drug-Resistant Focal Epilepsy
EASEE® System Pivotal Study for the United States of America
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy.
- Trial name
- EASEE4US (NCT07301346)
- Testing
- Implantable minimaly invasive brain stimulator
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Precisis US, Inc.
Generalized Epilepsy
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.
- Trial name
- SHINE (NCT06425159)
- Testing
- BHV-7000
- Where
- 109 sites in United States, Australia and 12 more
- Volunteers
- 27 people
- Sponsor
- Biohaven Therapeutics Ltd.
Tuberous Sclerosis Complex (TSC)
Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
1. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex. 2.
- Trial name
- Spectrum (NCT07403266)
- Testing
- YCJ-01 Full Spectrum cannbis Extract
- Where
- Spain
- Volunteers
- 84 people
- Sponsor
- Oils4Cure
Highly Drug-resistant Focal Epilepsy
A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.
- Trial name
- NCT02495844
- Testing
- UCB0942
- Where
- 18 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 55 people
- Sponsor
- UCB Biopharma S.P.R.L.
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L
Drug Resistant Epilepsy, Autism Spectrum Disorder
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
- Conditions
- Drug Resistant Epilepsy, Autism Spectrum Disorder, Chronic Migraine, Brain Tumor, Pediatric
- Trial name
- NCT06309251
- Testing
- ketogenic diet (as per clinical practice)
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Danone Nutricia SpA Società Benefit
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using…
- Trial name
- NCT05947656
- Testing
- NaviFUS System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Genovate-NaviFUS (Australia) Pty Ltd.
Epilepsy
Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures
The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had…
- Trial name
- NCT01648101
- Testing
- Retigabine 900mg/day, Retigabine 600mg/day
- Where
- 41 sites in Hong Kong, Malaysia and 5 more
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Epilepsy, Epilepsies, Partial
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic…
- Trial name
- NCT00210652
- Testing
- RWJ 333369:
- Volunteers
- 47 people
- Sponsor
- SK Life Science, Inc.
Drug Resistant Epilepsy, Epilepsy
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with…
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe, Seizures, Focal
- Trial name
- NCT06492720
- Testing
- Focused ultrasound (FUS) treatment
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- NaviFUS Corporation
Infantile Spasms (IS)
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
- Trial name
- NCT02829827
- Testing
- Radiprodil
- Where
- France
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma S.P.R.L.
Drug Resistant Epilepsy, Seizure
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
- Conditions
- Drug Resistant Epilepsy, Seizure, Seizure Disorder, Epilepsy
- Trial name
- NCT04999046
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- NaviFUS Corporation
Epilepsy, Alzheimer Disease
Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042
A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Trial name
- NCT07222878
- Testing
- NPT 2042 (Reference formula/Formulation 1), NPT 2042 (Test formula/Formulation 2)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- NeuroPro Therapeutics, Inc.
Focal Epilepsy
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Trial name
- RISE 3 (NCT06309966)
- Testing
- BHV-7000
- Where
- 150 sites in United States, Australia and 14 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.