Clinical trials: Refractory Epilepsy in Children
Epilepsy, Rare Diseases
Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy
This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor…
- Trial name
- CBD_RE (NCT05803434)
- Testing
- Cannabidiol oral solution
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Meyer Children's Hospital IRCCS
PCDH19-Related Epilepsy
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene…
- Trial name
- NCT03865732
- Testing
- Ganaxolone
- Where
- 12 sites in United States, Hungary and 3 more
- Volunteers
- 29 people
- Sponsor
- Marinus Pharmaceuticals
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
Refractory Epilepsy in Children, Refractory Epilepsy
Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials
The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol.
- Conditions
- Refractory Epilepsy in Children, Refractory Epilepsy, Epilepsy
- Trial name
- CBD-uN1que (NCT07668856)
- Testing
- Cannabidiol (CBD) oral solution
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- UMC Utrecht
Ketogenic Diet
Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups…
- Trial name
- NCT06255873
- Testing
- L- Carnitine, ketogenic diet
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Epilepsy
Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: Incidence, type and severity of adverse events (AEs) Effect on vital signs, including weight Effect…
- Trial name
- NCT02286986
- Testing
- Cannabidiol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Utah
Epilepsy Intractable
Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet…
- Trial name
- NCT03014752
- Testing
- Classical ketogenic diet, Modified Atkins diet
- Where
- Iran
- Volunteers
- 50 people
- Sponsor
- Tehran University of Medical Sciences
Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome
Evaluation of Keyo in Children With Epilepsy
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
- Conditions
- Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
- Trial name
- Keyo (NCT02915211)
- Testing
- Keyo
- Where
- 2 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- Vitaflo International, Ltd
Dravet Syndrome
An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome
Stoke Therapeutics is evaluating the safety and tolerability of single and multiple ascending doses of STK-001 in patients with Dravet syndrome.
- Trial name
- NCT04442295
- Testing
- STK-001 - Single Ascending Doses, STK-001 - Multiple Ascending Doses
- Where
- 18 sites in United States
- Volunteers
- 62 people
- Sponsor
- Stoke Therapeutics, Inc
Epileptic Spasms, Failed Hormonal Therapy
Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
This study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified Atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized…
- Trial name
- TOPAMAD (NCT05958160)
- Testing
- Modified Atkins diet, Topiramate
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Lady Hardinge Medical College
Refractory Epilepsy
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment.
- Trial name
- SMAD (NCT01899898)
- Testing
- Simplified Modified Atkins Diet, Antiepileptic drugs alone
- Where
- India
- Volunteers
- 81 people
- Sponsor
- Lady Hardinge Medical College
Intractable Epilepsy
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
The primary aim of the study is to determine the effect of reducing the number and/or dose of anti epileptic drugs on an individual's quality of life and seizure control in people with difficult to control epilepsy and who are on…
- Trial name
- NCT00647322
- Testing
- Reduction of anti-epileptic medications, No drug change
- Where
- United Kingdom
- Volunteers
- 64 people
- Sponsor
- Institute of Child Health
Resistant Epilepsy, Drug, Adolescent Epilepsy
Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies
EudraCT: 2018-003887-29 Objective:To evaluate the safety and efficacy of: MGCND00EP1 from MGC PHARMACEUTICALS d.o.o. Study Design: Randomized, double blind, placebo controlled parallel grouped study Sample Size: 103 subjects…
- Conditions
- Resistant Epilepsy, Drug, Adolescent Epilepsy, Children Epilepsy, Children and Adolescents With Resistant Epilepsies
- Trial name
- NCT04406948
- Testing
- MGCND00EP1, ECG, EEG
- Where
- 2 sites in Israel, Slovenia
- Sponsor
- MGC Pharmaceuticals d.o.o
Refractory Childhood Epilepsy
Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy
In this study, the efficacy of add-on modified Atkins diet will be compared with add-on Levetiracetam in children with refractory epilepsy in a randomized open label trial.
- Trial name
- LEVEMAD (NCT04172311)
- Testing
- Modified Atkins Diet, Levetiracetam
- 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, Epilepsy (Treatment Refractory)
Risk Factors for Drug-Resistant Epilepsy in Children
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification…
- Trial name
- PED-DRE (NCT07723287)
- Testing
- No Intervention: Observational Cohort
- Where
- Vietnam
- Volunteers
- 375 people
- Sponsor
- Pham Ngoc Thach University of Medicine
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 in Children
Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy
The goal of this observational study is to evaluate the effectiveness of Magnetoencephalography (MEG) in the preoperative assessment of children with refractory epilepsy, particularly in identifying the seizure focus, and to…
- Trial name
- NCT07064421
- Testing
- Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography, Stereo-electroencephalography/Electrocorticography
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Epilepsy; Seizure
Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
- Trial name
- DBS-VNS-ES (NCT07010276)
- Testing
- DBS Arm, VNS arm
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- The Hospital for Sick Children
Transcranial Electric Stimulation, tDCS
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
Epilepsy is one of the most common neurological diseases, affecting between 0.5% and 1% of the general population. Therefore, new diagnostic and treatment methods are having a big impact on society.
- Conditions
- Transcranial Electric Stimulation, tDCS, Epilepsy, Pharmacoresistant
- Trial name
- PerEpi2 (NCT06212609)
- Testing
- transcranial electrical stimulation therapy
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens