Clinical trials: Pediatric Epilepsy
Epilepsy
Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose in 3 age cohorts of pediatric patients with epilepsy (age 2-5 years, age 6-11 years, and age 12-16 years).
- Trial name
- NCT03222349
- Testing
- Diazepam Buccal Film
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- Aquestive Therapeutics
Epilepsy
Pediatric Epilepsy Study
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
- Trial name
- NCT00050947
- Testing
- oxcarbazepine
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 94 people
- Sponsor
- Novartis Pharmaceuticals
Electroencephalographic Neonatal Seizures, Epilepsy
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of…
- Trial name
- LENS (NCT04519645)
- Testing
- Lacosamide intravenous, Lacosamide oral, Active Comparator
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 29 people
- Sponsor
- UCB Biopharma SRL
Epilepsies, Partial
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00620555
- Testing
- gabapentin
- Where
- 22 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or…
- Trial name
- NCT04627285
- Testing
- Lacosamide
- Where
- 15 sites in Georgia, Hungary and 4 more
- Volunteers
- 48 people
- Sponsor
- UCB Biopharma SRL
Epilepsy
Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine…
- Trial name
- NCT05818930
- Testing
- REMI
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- Epitel, Inc.
Dravet Syndrome, Epilepsy
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
This is a Phase I, open-label, randomized, single-center, two-way cross-over study evaluating the relative bioavailability, pharmacokinetics, safety, and palatability of two formulations of stiripentol (Diacomit®), indicated in…
- Conditions
- Dravet Syndrome, Epilepsy, Childhood, Epileptic Encephalopathy
- Trial name
- STILIQ (NCT07176832)
- Testing
- Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®)
- Where
- 2 sites in France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Biocodex
Epilepsy
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.
- Trial name
- NCT00615615
- Testing
- Levetiracetam
- Volunteers
- 216 people
- Sponsor
- UCB Pharma
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.
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Childhood Absence Epilepsy
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03336242
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Radius Pharmaceuticals, Inc.
SCN2A-DEE, Epilepsy
A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy
This prospective observational study is designed to assess the individualized baseline disease burden in pediatric participants aged 1 year to 16 years, with early-onset SCN2A-DEE by characterizing and quantifying changes in…
- Trial name
- NCT05407727
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Praxis Precision Medicines
Epileptic Encephalopathy, SCN2A Encephalopathy
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy
- Trial name
- NCT07019922
- Testing
- 1mg elsunersen, 0.5mg elsunersen
- Where
- 10 sites in United States, Brazil and 2 more
- Volunteers
- 40 people
- Sponsor
- Praxis Precision Medicines
Infantile Spasms
Open-label Extension to Protocol 1042-0500
To allow open-label extension to patients who have completed Protocol 1042-0500
- Trial name
- NCT00442104
- Testing
- Ganaxolone
- Where
- 14 sites in United States
- Volunteers
- 54 people
- Sponsor
- Marinus Pharmaceuticals
Partial Seizures
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
- Trial name
- PEACH (NCT03340064)
- Testing
- Levetiracetam
- Where
- 21 sites in Japan
- Volunteers
- 38 people
- Sponsor
- UCB Japan Co. Ltd.
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.
Lennox Gastaut Syndrome
Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome
This is an open-label, multi-center study of carisbamate in adult and pediatric subjects with LGS, with single- and multiple-dose PK assessments from Days 1 through 73.
- Trial name
- NCT03731715
- Testing
- Carisbamate
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- SK Life Science, Inc.
Partial Epilepsy
Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.
- Trial name
- NCT04903314
- Testing
- Xcopri
- Where
- 13 sites in United States, Hungary and 1 more
- Volunteers
- 26 people
- Sponsor
- SK Life Science, Inc.
Refractory Epilepsy
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms.
- Trial name
- NCT03062514
- Testing
- PINS Vagus Nerve Stimualtor
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Epilepsy, Partial Seizures
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with…
- Trial name
- NCT01063764
- Testing
- Levetiracetam
- Where
- 29 sites in Japan
- Volunteers
- 73 people
- Sponsor
- UCB Japan Co. Ltd.