Clinical trials: Intractable Epilepsy
Tuberous Sclerosis Complex-associated Refractory Seizures
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures.
- Trial name
- EXIST-3 (NCT01713946)
- Testing
- RAD001, Antiepileptic drug (1 to 3 only), open label RAD001 (only used for post-extension phase)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 366 people
- Sponsor
- Novartis Pharmaceuticals
Epileptic Spasms
Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms
Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of children.
- Trial name
- NCT03807141
- Testing
- Modified Atkins diet
- Where
- India
- Volunteers
- 90 people
- Sponsor
- Lady Hardinge Medical College
Epilepsy, Drug Resistant
Deep Brain Stimulation Post Failed Vagal Nerve Stimulation
This is a multicenter, non-blinded, patient preference comparative trial for efficacy of deep brain stimulation (DBS) on drug-resistant epilepsy compared to continued vagal nerve stimulation (VNS) optimization in children with…
- Trial name
- DBSpostVNS (NCT04181229)
- Testing
- Deep brain stimulation
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- The Hospital for Sick Children
Epilepsy, Lennox Gastaut Syndrome
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed.
- Trial name
- FFA-LGS (NCT02655198)
- Testing
- Fenfluramine
- Where
- Belgium
- Volunteers
- 13 people
- Sponsor
- KU Leuven
Refractory Epilepsy
Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy
Refractory epilepsies caused by an autoimmune mechanisms lead in children to progressive neurodegeneration. Immunomodulation therapy is effective only in a half of such cases. New approaches are undertaken.
- Trial name
- EPIMSC (NCT03676569)
- Testing
- ADRC transplantation in autoimmune refractory epilepsy
- Volunteers
- 6 people
- Sponsor
- Mossakowski Medical Research Centre Polish Academy of Sciences
Other Forms of Epilepsy, Treatment Resistant
TDCs to Treat Drug-resistant Epilepsy
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide.
- Trial name
- NCT05825274
- Testing
- Active Cathodal tDCS
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Spanish Foundation for Neurometrics Development
Epilepsy Intractable
5-SENSE Score Validation Study
The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG).
- Trial name
- NCT06138808
- Testing
- Stereoelectroencephalography (SEEG)
- Where
- 19 sites in United States, Australia and 10 more
- Volunteers
- 400 people
- Sponsor
- Duke University
Refractory Infantile Spasms
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.
- Trial name
- NCT03976076
- Testing
- JBPOS0101
- Where
- 23 sites in United States, South Korea
- Volunteers
- 16 people
- Sponsor
- Bio-Pharm Solutions Co., Ltd.
Infantile Spasms
Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy
Infantile spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult.
- Trial name
- NCT01549288
- Testing
- modified Atkins diet, no dietetic input
- Where
- India
- Sponsor
- Lady Hardinge Medical College
Drug Resistant Epilepsy
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on…
- Trial name
- NCT02982824
- Testing
- Magnesium
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Epilepsy, Seizures
A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy
The purpose of this study is to evaluate the effectiveness and safety of topiramate (an antiepileptic medication) in patients with epilepsy.
- Trial name
- NCT00266591
- Testing
- topiramate
- Volunteers
- 51 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Epilepsy
Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy
This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-surgical assessment.
- Trial name
- GALVANI PS-1 (NCT04782869)
- Testing
- transcranial direct current stimulation
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Epilepsy, Seizures
EpiCare@Home Validation Study for Focal Onset Seizures
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures.
- Conditions
- Epilepsy, Seizures, Seizures, Focal, Seizure, Refractory
- Trial name
- NCT05738226
- Testing
- EpiCare@Home, wearable multimodal seizure monitoring system
- Where
- United States
- Sponsor
- Byteflies
Epilepsy, Treatment
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy
This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.
- Trial name
- NCT05160350
- Testing
- Probiotic
- Where
- Iran
- Volunteers
- 42 people
- Sponsor
- Mazandaran University of Medical Sciences
Epilepsy, Drug Resistant Epilepsy
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant…
- Trial name
- GALVANI GS-3 (NCT06334952)
- Testing
- transcranial direct current stimulation
- Where
- 7 sites in France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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
Epilepsy, Epileptic Encephalopathy
Tele-epic (Telemedicine for Epilepsy Care)
Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control, surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side effects.
- Conditions
- Epilepsy, Epileptic Encephalopathy, Refractory Epilepsy
- Trial name
- Tele-epic (NCT04496310)
- Testing
- Telemedicine
- Where
- 2 sites in Italy
- Volunteers
- 600 people
- Sponsor
- Azienda Usl di Bologna
Pediatric Epileptic Syndrome, Partial-onset Seizures
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic…
- Trial name
- NCT04015141
- Testing
- Perampanel Oral Suspension, Perampanel Tablet
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 100 people
- Sponsor
- Eisai Inc.
Epilepsies, Partial
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five…
- Trial name
- NCT00215215
- Testing
- Vagus Nerve Stimulation Therapy
- Where
- 23 sites in United States
- Volunteers
- 360 people
- Sponsor
- Cyberonics, Inc.
Epileptic Seizure, Epilepsy Intractable
REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
People with central lobe epilepsy (CLE), with seizures arising from the primary sensorimotor cortex, typically show a high rate of convulsive seizures that do not respond to anti-epileptic drugs, but have a large impact on…
- Conditions
- Epileptic Seizure, Epilepsy Intractable, Motor Seizure
- Trial name
- REC2Stim (NCT04158531)
- Testing
- ECoG sensing and stimulation
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- UMC Utrecht