Clinical trials: Refractory Epilepsy in Children
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.
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
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.
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
Refractory Epilepsy in Children
Does VNS Interact With the Serotonergic and Immune System in Children With Intractable Epilepsy?
Clinical randomized controlled observer blinded add-on design. Additionally there will be a non-controlled follow-up phase of the study.
- Trial name
- NCT01378611
- Testing
- Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USA
- Where
- 2 sites in Netherlands
- Volunteers
- 45 people
- Sponsor
- Epilepsiecentrum Kempenhaeghe
Neuroblastoma
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
- Trial name
- NCT04106219
- Testing
- LY3295668 Erbumine, Topotecan, Cyclophosphamide
- Where
- 17 sites in United States, Australia and 7 more
- Volunteers
- 71 people
- Sponsor
- Eli Lilly and Company
Epilepsy
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs).
- Trial name
- NCT01118455
- Testing
- Vagus Nerve Stimulation (VNS) Therapy, Anti-Epileptic Drug (AED)
- Where
- 19 sites in Austria, Belgium and 3 more
- Volunteers
- 134 people
- Sponsor
- Cyberonics, Inc.
Epilepsy, Partial
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures.
- Trial name
- NCT00175890
- Testing
- Levetiracetam
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 116 people
- Sponsor
- UCB Pharma
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
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
Epilepsy, Partial
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial…
- Trial name
- NCT00105040
- Testing
- Levetiracetam
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 87 people
- Sponsor
- UCB Pharma
Drug Resistant Epilepsy, Autism Spectrum Disorder
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
- Conditions
- Drug Resistant Epilepsy, Autism Spectrum Disorder, Chronic Migraine, Brain Tumor, Pediatric
- Trial name
- NCT06309251
- Testing
- ketogenic diet (as per clinical practice)
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Danone Nutricia SpA Società Benefit
Drug Resistant Epilepsy, Ketogenic Dieting
Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and…
- Trial name
- KEOPS (NCT06075485)
- Testing
- Ketocal
- Where
- France
- Volunteers
- 133 people
- Sponsor
- Nutricia Nutrition Clinique
Partial Epilepsy in Children and Adolescents
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by…
- Trial name
- NCT00988156
- Testing
- Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate
- Where
- 91 sites in Austria, Bosnia and Herzegovina and 19 more
- Volunteers
- 304 people
- Sponsor
- Bial - Portela C S.A.
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