Clinical trials: Pediatric Epilepsy
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
Seizure, Epilepsy
Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria
Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae.
- Conditions
- Seizure, Epilepsy, Cerebral Malaria
- Trial name
- LVT1 (NCT01660672)
- Testing
- LEVETIRACETAM
- Where
- Malawi
- Volunteers
- 7 people
- Sponsor
- University of Rochester
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.
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.
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Epilepsy
Study in Pediatric Subjects With Epilepsy
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
- Trial name
- NCT01494584
- Testing
- ezogabine/retigabine
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- GlaxoSmithKline
Epilepsy, Partial
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is…
- Trial name
- NCT00150709
- Testing
- Levetiracetam
- Volunteers
- 223 people
- Sponsor
- UCB Pharma
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Epilepsy, Epilepsy in Children
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).
- Conditions
- Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease
- Trial name
- EPIK (NCT04639310)
- Testing
- XEN496
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 8 people
- Sponsor
- Xenon Pharmaceuticals Inc.
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.
Childhood Absence Epilepsy
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03355300
- Testing
- Cannabidiol Oral Solution
- Where
- 9 sites in United States
- Volunteers
- 11 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Epilepsy in Children
Getting SMART for Pediatric Epilepsy
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
- Trial name
- NCT05439876
- Testing
- Melatonin
- Where
- Taiwan
- Volunteers
- 147 people
- Sponsor
- National Taiwan University Hospital
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.
Epilepsy
Bridging the Childhood Epilepsy Treatment Gap in Africa
About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs).
- Trial name
- BRIDGE (NCT04290975)
- Testing
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
- Where
- 3 sites in Nigeria
- Volunteers
- 1,672 people
- Sponsor
- Vanderbilt University Medical Center
Pediatric Epilepsy, Epilepsy Surgery
High Frequency Oscillation in Pediatric Epilepsy Surgery
High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue.
- Conditions
- Pediatric Epilepsy, Epilepsy Surgery, High Frequency Oscillation
- Trial name
- HFO (NCT03790280)
- Testing
- HFO analysis
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of California, Los Angeles
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
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
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
- Trial name
- NCT01964560
- Testing
- Lacosamide
- Where
- 141 sites in United States, Argentina and 33 more
- Volunteers
- 540 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsy, Anxiety
Use of Clobazam for Epilepsy and Anxiety
This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric patients with epilepsy and clinically significant anxiety will be recruited and if enrolled will receive active treatment, involving…
- Trial name
- NCT03371836
- Testing
- Clobazam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Photosensitive Epilepsy
Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).
Sunflower Syndrome (also referred to as Self-induced Photosensitive Epilepsy) is a rare epileptic disorder characterized by a distinctive seizure that manifests itself in a highly stereotyped physical behavior.
- Trial name
- NCT03790137
- Testing
- Fenfluramine Hydrochloride
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Elizabeth Anne Thiele