Clinical trials: Refractory Epilepsy in Children
Drug Resistant Epilepsy, Ketogenic Diet
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
According to the World Health Organization, more than 50 million people have epilepsy. Among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment.
- Conditions
- Drug Resistant Epilepsy, Ketogenic Diet, Feasibility, Tolerability
- Trial name
- NCT05697887
- Testing
- Ketogenic diet
- Where
- Vietnam
- Volunteers
- 45 people
- Sponsor
- Number 2 Children's Hospital, Ho Chi Minh City
CDKL5 Deficiency Disorder
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
- Trial name
- Marigold (NCT03572933)
- Testing
- ganaxolone
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 101 people
- Sponsor
- Marinus Pharmaceuticals
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.
Developmental and Epileptic Encephalopathy, Epilepsy in Children
Developmental and Epileptic Encephalopathies Diagnosed Via Long-read Genome Sequencing
This study focuses on children with Developmental and Epileptic Encephalopathy (DEE), a severe form of epilepsy that often has a genetic origin.
- Trial name
- EEPILOG (NCT07396883)
- Testing
- Long-read Whole Genome Sequencing (lrWGS)
- Where
- 4 sites in France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Strasbourg, France
Epilepsy
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet…
- Trial name
- NCT01278966
- Testing
- The Modified Atkins Diet
- Where
- Norway
- Volunteers
- 21 people
- Sponsor
- Oslo University Hospital
Epilepsies, Focal, Pediatrics
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities.
- Conditions
- Epilepsies, Focal, Pediatrics, Drug Resistant Epilepsy
- Trial name
- EPITRACT (NCT03268824)
- Testing
- Electroencephalogram (EEG), Diffusion Tensor imaging, Language assessment
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
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
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
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
Drug Resistant Epilepsy
the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy
- Trial name
- NCT05485558
- Testing
- N-acetyl cysteine, NAc
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Tanta University
Epilepsy
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
- Trial name
- NCT02170064
- Testing
- BIA 2-093 (Eslicarbazepine acetate)
- Where
- Romania
- Volunteers
- 35 people
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Dietary Therapy in Children With Refractory Epilepsy
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6…
- Trial name
- NCT01983163
- Testing
- Ketogenic diet (2.5 to 4:1), Modified Atkin's diet
- Where
- India
- Volunteers
- 30 people
- Sponsor
- All India Institute of Medical Sciences
Epilepsy, Mental Retardation
Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy
This is an open randomized controlled study in children with mental retardation and refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment with the antiepileptic drug (AED), not tried by the…
- Trial name
- NCT00552526
- Testing
- Ketogenic diet, Antiepileptic drug (AED)
- Where
- Norway
- Volunteers
- 60 people
- Sponsor
- Oslo University Hospital
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
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
Drug Resistant Epilepsy
Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form.
- Trial name
- NCT05539287
- Testing
- Lactobacillus-Based Capsule
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
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, 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
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