Clinical trials: Drug-Resistant Epilepsy
Epilepsy, Focal Seizures, Partial Seizures
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy.
- Trial name
- OPUS (NCT03283371)
- Testing
- Natalizumab
- Where
- 31 sites in United States
- Volunteers
- 67 people
- Sponsor
- Biogen
Epilepsy, Seizures, Epileptic
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
- Trial name
- NCT05518578
- Testing
- SPN-817
- Where
- 10 sites in United States, Australia
- Volunteers
- 60 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Refractory Epilepsy, Focal Seizure
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers…
- Conditions
- Refractory Epilepsy, Focal Seizure, Seizures, Focal, Seizures
- Trial name
- NCT04770337
- Testing
- STARSTIM device
- Where
- 32 sites in United States, Belgium and 2 more
- Volunteers
- 127 people
- Sponsor
- Neuroelectrics Corporation
Tuberous Sclerosis Complex, Epilepsy
Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy (RESTOR-1)
This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC).
- Trial name
- RESTOR-1 (NCT07680322)
- Testing
- AV078
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- Aeovian Pharmaceuticals, Inc.
Intractable Epilepsy
Ketogenic Diet Drink Study
An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or…
- Trial name
- NCT03196271
- Testing
- Ketocal 2.5:1
- Where
- 9 sites in United Kingdom
- Volunteers
- 26 people
- Sponsor
- Nutricia UK Ltd
Refractory Epilepsy
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
- Trial name
- VNSRE (NCT02378792)
- Testing
- Vagus Nerve Stimulation
- Where
- 5 sites in China
- Volunteers
- 300 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Epilepsy, Alzheimer Disease
Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects
Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Trial name
- NCT05503511
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- NeuroPro Therapeutics, Inc.
Refractory Epilepsy, Development Delay
European Non-interventional Study on Refractory Epilepsy With Developmental Delay
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).
- Trial name
- NCT04398667
- Where
- 19 sites in France, Germany and 2 more
- Volunteers
- 93 people
- Sponsor
- Zogenix, Inc.
Drug Resistant Epilepsy, Epilepsy
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in…
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Seizures, Focal, Seizure
- Trial name
- NCT06388707
- Testing
- NaviFUS System
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- NaviFUS Corporation
Focal Epilepsy, Drug-resistant Focal Epilepsy
RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents…
- Trial name
- AURORA (NCT07823465)
- Testing
- NeuroPace RNS System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- NeuroPace
Refractory Epilepsy in Children
Does VNS Interact With the Serotonergic and Immune System in Children With Intractable Epilepsy?
Clinical randomized controlled observer blinded add-on design. Additionally there will be a non-controlled follow-up phase of the study.
- Trial name
- NCT01378611
- Testing
- Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USA
- Where
- 2 sites in Netherlands
- Volunteers
- 45 people
- Sponsor
- Epilepsiecentrum Kempenhaeghe
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
Intellectual Disability, Developmental Delay
Biomarker for Creatine Deficiency Syndromes (BioCDS)
Development of a new mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample
- Conditions
- Intellectual Disability, Developmental Delay, Movement Disorder, Behavioral Disorder
- Trial name
- BioCDS (NCT02934854)
- Where
- 4 sites in Egypt, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Refractory Epilepsy
Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age…
- Trial name
- NCT00228969
- Testing
- RWJ-333369
- Where
- 61 sites in United States, Argentina and 6 more
- Sponsor
- SK Life Science, Inc.
Childhood Absence Epilepsy
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03336242
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Epilepsies, Myoclonic, Drug Resistant Epilepsy
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
- Trial name
- NCT04457687
- Testing
- Lorcaserin
- Where
- 22 sites in United States, Canada
- Sponsor
- Eisai Inc.
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 Epilepsy
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms.
- Trial name
- NCT03062514
- Testing
- PINS Vagus Nerve Stimualtor
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Refractory Epilepsy
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
- Trial name
- ANT-DBS-RE (NCT02602899)
- Testing
- PINS'Deep Brain Stimulator device
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Lennox-Gastaut Syndrome
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3…
- Trial name
- NCT02318537
- Testing
- Cannabidiol Oral Solution
- Sponsor
- INSYS Therapeutics Inc