Clinical trials: Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures
An Open-label Study of XEN1101 in Epilepsy
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of…
- Trial name
- X-TOLE4 (NCT05718817)
- Testing
- XEN1101
- Where
- 152 sites in United States, Argentina and 23 more
- Volunteers
- 880 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
The goal of this real world data study is to evaluate the clinical utility of remote patient monitoring solution (using Byteflies' EpiCare@Home with reduced EEG montage and other vital signs) with Dravet and LGS patients (ages 3…
- Trial name
- TETRIS (NCT07225231)
- Testing
- Byteflies Remote patient monitoring solution (with reduced EEG)
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Byteflies
Juvenile Myoclonic Epilepsy
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
- Trial name
- NCT07723963
- Testing
- JZP926 capsule
- Where
- 20 sites in United States
- Volunteers
- 260 people
- Sponsor
- Jazz Pharmaceuticals
Focal Onset Seizures
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.
- Trial name
- NCT06798896
- Testing
- SPN-817
- Where
- 63 sites in United States, Australia and 3 more
- Volunteers
- 216 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Focal Epilepsy
A 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 2 (NCT06132893)
- Testing
- BHV-7000
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.
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.
Epilepsy, Generalized, Epilepsy, Absence
A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period.
- Trial name
- NCT06769659
- Testing
- NPT 2042
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- NeuroPro Therapeutics, Inc.
Motor Epilepsy
Combined CM and STN Stimulation for Motor Epilepsy
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant…
- Trial name
- CoSMos (NCT07458217)
- Testing
- Deep brain stimulation
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Focal Epilepsy
A Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 in Adult Patients With Focal Epilepsy
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.
- Trial name
- NCT06612775
- Testing
- Test drug CB03-154 5mg group, Test drug CB03-154 10mg group, Test drug CB03-154 20mg group
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Drug Resistant Epilepsy
Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.
- Trial name
- iVEAcare-FS (NCT07640191)
- Testing
- iVEAcare Neuromodulation System
- Where
- 7 sites in Australia
- Volunteers
- 30 people
- Sponsor
- iVEAcare
Dravet Syndrome
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
- Trial name
- ORCHID (NCT06118255)
- Testing
- fenfluramine
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 25 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsy (Treatment Refractory)
Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring
TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring.
- Trial name
- TRCE (NCT07821697)
- Testing
- EEG Record only
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Adraxe Corp.
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
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792…
- Trial name
- NCT02497235
- Testing
- TAK-935, [18F]MNI-792 (tracer)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Takeda
Epilepsy
TAK-935 Multiple Rising Dose Study in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.
- Trial name
- NCT02539134
- Testing
- TAK-935
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Dravet Syndrome
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with…
- Trial name
- ARGUS (NCT04462770)
- Testing
- Clemizole HCl
- Where
- 68 sites in United States, Argentina and 8 more
- Volunteers
- 150 people
- Sponsor
- Epygenix
Epilepsy, Lennox Gastaut Syndrome
RNS System LGS Feasibility Study
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or…
- Conditions
- Epilepsy, Lennox Gastaut Syndrome, Lennox-Gastaut Syndrome, Intractable, Seizures
- Trial name
- NCT05339126
- Testing
- RNS System
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- NeuroPace
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
Seizures, Seizures, Focal
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures.
- Conditions
- Seizures, Seizures, Focal, Seizure, Partial Onset, Seizure Disorder, Partial
- Trial name
- NCT06534502
- Testing
- Zonisamide Oral Product
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Azurity Pharmaceuticals
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE.
- Trial name
- NCT06719141
- Testing
- LP352
- Where
- 116 sites in United States, Australia and 15 more
- Volunteers
- 367 people
- Sponsor
- Longboard Pharmaceuticals