Clinical trials: Drug-Resistant Focal Epilepsy
Drug-Resistant Epilepsy, Focal-Onset Seizures
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
- Trial name
- NCT03370120
- Testing
- Padsevonil
- Where
- 156 sites in United States, Australia and 25 more
- Volunteers
- 406 people
- Sponsor
- UCB Biopharma SRL
Seizures
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.
- Trial name
- NCT04686786
- Testing
- CVL-865
- Where
- 56 sites in United States, Australia and 5 more
- Volunteers
- 105 people
- Sponsor
- AbbVie
Refractory Epilepsy
Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
This is a Phase 2 double-blind, randomized, placebo-controlled study to assess the safety and efficacy of ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC) in subjects with focal…
- Trial name
- NCT04153175
- Testing
- ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)
- Where
- 11 sites in Australia, Israel
- Volunteers
- 30 people
- Sponsor
- Cerebral Therapeutics LLC
Epilepsy, Partial Seizure
RNS System RESPONSE Study
To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.
- Conditions
- Epilepsy, Partial Seizure, Neurostimulator; Complications, Drug Resistant Epilepsy
- Trial name
- RESPONSE (NCT04839601)
- Testing
- RNS System
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- NeuroPace
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.
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
Epilepsy, Focal Epilepsy
Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes
The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in…
- Conditions
- Epilepsy, Focal Epilepsy, Drug Resistant Epilepsy
- Trial name
- NCT06366009
- Testing
- NaoX in-ear EEG system
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Przemyslaw Kunert
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
Refractory Epilepsy
Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal…
- Trial name
- NCT02866240
- Testing
- Cathodal Transcranial Direct Current Stimulation (tDCS).
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Neuroelectrics Corporation
Focal Epilepsy
Long-term Safety and Tolerability of BHV-7000
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
- Trial name
- NCT06443463
- Testing
- BHV-7000
- Where
- 283 sites in United States, Argentina and 25 more
- Volunteers
- 660 people
- Sponsor
- Biohaven Therapeutics Ltd.
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
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.
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.
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.
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
Mesial Temporal Lobe Epilepsy
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe…
- Trial name
- EPIC (NCT05135091)
- Testing
- NRTX-1001
- Where
- 36 sites in United States
- Volunteers
- 88 people
- Sponsor
- Neurona Therapeutics
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
Drug-resistant Epilepsy, Focal-Onset Seizures
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset…
- Trial name
- ARISE (NCT03373383)
- Testing
- Padsevonil
- Where
- 148 sites in United States, Australia and 17 more
- Volunteers
- 411 people
- Sponsor
- UCB Biopharma S.P.R.L.
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.
Epilepsy, Partial
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
- Trial name
- NCT01332539
- Testing
- no intervention
- Volunteers
- 240 people
- Sponsor
- GlaxoSmithKline