Clinical trials: Epilepsy in Children
Ketogenic Dieting, Epilepsy
Evaluation of Krio in Children and Adults With Epilepsy
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency…
- Conditions
- Ketogenic Dieting, Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome
- Trial name
- Krio (NCT03202108)
- Testing
- Krio
- Sponsor
- Vitaflo International, Ltd
Dravet Syndrome
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS.
- Trial name
- NCT06660394
- Testing
- LP352
- Where
- 105 sites in United States, Australia and 16 more
- Volunteers
- 108 people
- Sponsor
- Longboard Pharmaceuticals
Epilepsy, Lennox-Gastaut Syndrome
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).
- Trial name
- GWPCARE4 (NCT02224690)
- Testing
- GWP42003-P 20 mg/kg/day Dose
- Where
- 24 sites in United States, Netherlands and 1 more
- Volunteers
- 171 people
- Sponsor
- Jazz Pharmaceuticals
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
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
Epilepsy
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
- Trial name
- NCT02358538
- Testing
- Ganaxolone
- Where
- 10 sites in United States, Italy
- Volunteers
- 30 people
- Sponsor
- Marinus Pharmaceuticals
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
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 1 month to < 17 years of age with epilepsy.
- Trial name
- ASPIRE (NCT02710890)
- Testing
- Lacosamide
- Where
- 23 sites in United States, Hungary and 3 more
- Volunteers
- 103 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Inherited Mitochondrial Disease, Including Leigh Syndrome
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in…
- Trial name
- MITO-001 (NCT02023866)
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Epilepsy
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
- Trial name
- NCT00961441
- Testing
- Keppra XR
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsy, Partial Seizures
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either…
- Trial name
- PERIWINKLE (NCT01389596)
- Testing
- Pregabalin add-on therapy
- Where
- 86 sites in United States, Belgium and 16 more
- Volunteers
- 295 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy, Lennox Gastaut Syndrome
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
- Trial name
- GWPCARE3 (NCT02224560)
- Testing
- GWP42003-P
- Where
- 29 sites in United States, France and 2 more
- Volunteers
- 225 people
- Sponsor
- Jazz Pharmaceuticals
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
Pediatric Epilepsy
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
- Trial name
- NCT00646711
- Testing
- Depakote Delayed-Release/Depakote Sprinkle, Depakote ER
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Abbott
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.
Infantile Spasms
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug.
- Trial name
- SoluWest (NCT02220114)
- Testing
- Vigabatrin: Vigabatrin new ST formulation then Sabril®
- Where
- 12 sites in France
- Volunteers
- 38 people
- Sponsor
- Orphelia Pharma
Epilepsy
Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of lamotrigine monotherapy on newly diagnosed typical absence seizure in children and adolescents in Japan and South Korea.
- Trial name
- NCT01431976
- Testing
- Lamictal
- Where
- 14 sites in Japan, South Korea
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Epilepsy
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).
- Trial name
- NCT00938431
- Testing
- Lacosamide
- Where
- 21 sites in United States, Belgium and 1 more
- Volunteers
- 47 people
- Sponsor
- UCB Pharma
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
- Trial name
- NCT05163314
- Testing
- Soticlestat
- Where
- 116 sites in United States, Australia and 18 more
- Volunteers
- 352 people
- Sponsor
- Takeda
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.