Clinical trials: Focal 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
Drug Resistant Epilepsy
Fluorescence Guided Focal Cortical Dysplasia Surgery
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant…
- Trial name
- FLUOFOCODYS (NCT07657975)
- Testing
- 5-ALA (Gliolan)
- Where
- 2 sites in France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Drug-Resistant Focal Epilepsy
Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal…
- Trial name
- NCT07764718
- Testing
- Temporal Interference Stimulation, Direct Electrical Stimulation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Refractory Epilepsy, Focal Epilepsy
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and…
- Conditions
- Refractory Epilepsy, Focal Epilepsy, Focal Cortical Dysplasia
- Trial name
- SPREAD (NCT03321240)
- Testing
- visual and quantitative SEEG signal analysis, Resective epilepsy surgery procedure
- Where
- 11 sites in France
- Volunteers
- 240 people
- Sponsor
- University Hospital, Strasbourg, France
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.
Focused Ultrasound, MR-guided FUS
Focused Ultrasound for Drug-resistant Epilepsy
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition…
- Conditions
- Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy, Drug Resistant Epilepsy
- Trial name
- NCT06292494
- Testing
- Exablate 4000 Transcranial MRgfUS System
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
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.
Epilepsy, Drug Resistant
The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
The aim of this study is to evaluate the clinical efficacy of everolimus as an adjunctive therapy for refractory epilepsy. The significance lies in addressing whether the mTOR inhibitor sirolimus has antiepileptic adjunctive…
- Trial name
- NCT07095933
- Testing
- Everolimus
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Xuanwu Hospital, Beijing
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
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
Highly Drug-resistant Focal Epilepsy
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy.
- Trial name
- NCT02625090
- Testing
- UCB0942
- Where
- 15 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 42 people
- Sponsor
- UCB Biopharma SRL
Drug Resistant Epilepsy, Epilepsy, Drug Resistant
Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy
This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory
- Trial name
- NCT03860298
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- NaviFUS Corporation
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
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
Patients With Drug-resistant Focal Epilepsy, SEEG as Part of Presurgical Evaluation
Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure…
- Trial name
- EPIDREAM 3 (NCT07605858)
- Testing
- Direct Electric Stimulation (DES)
- Where
- 2 sites in United States, France
- Volunteers
- 20 people
- Sponsor
- Hospices Civils de Lyon
Focal Epilepsy
Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy
This study will evaluate a type of Magnetic Resonance Imaging (MRI) sequence called arterial spin labeling (ASL). The investigators hope that ASL can better localize areas of the brain (lesions) that cause epilepsy.
- Trial name
- NCT01772654
- Testing
- Arterial Spin Labeled (ASL) MRI sequence
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Mayo Clinic
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
Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy
The goal of this clinical trial is to assess the feasibility, safety, and tolerance of MRI-guided High-Intensity Focused Ultrasound (HIFU) for the treatment of drug-resistant focal epilepsy in adult patients with MRI-visible…
- Trial name
- EPIFUS (NCT07591350)
- Testing
- MR-guided HIFU thermoablation, EEG, MRI
- Volunteers
- 13 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Epilepsy, Seizures, Focal
Thermocoagulation in Drug Resistant Focal Epilepsy
Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data.
- Conditions
- Epilepsy, Seizures, Focal, Epilepsy Intractable, Epilepsies, Partial
- Trial name
- NCT05248269
- Testing
- Radiofrequency thermocoagulation
- Where
- Russia
- Volunteers
- 75 people
- Sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Epilepsies, Partial, Epilepsy Intractable
Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies
Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant.
- Trial name
- NCT05015868
- Testing
- Standard of care, Functional magnetic resonance imaging-Electroencephalogram combined analysis, High density- electroencephalogram or 7 Tesla magnetic resonance imaging
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- IRCCS Eugenio Medea