Clinical trials: Neonatal Seizure
Tuberous Sclerosis Complex, Seizures
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo.
- Trial name
- NCT02544763
- Testing
- GWP42003-P
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 224 people
- Sponsor
- Jazz Pharmaceuticals
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
Neonatal Seizures
Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide.
- Trial name
- NCT03107507
- Testing
- Levetiracetam, Phenobarbital
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Epilepsy, Lennox Gastaut Syndrome
RNS System LGS Feasibility Study
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or…
- Conditions
- Epilepsy, Lennox Gastaut Syndrome, Lennox-Gastaut Syndrome, Intractable, Seizures
- Trial name
- NCT05339126
- Testing
- RNS System
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- NeuroPace
Epilepsy, Epilepsy, Temporal Lobe
Early Surgical Intervention to Treat Epilepsy
The purpose of this trial is to compare the effectiveness of early surgical intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe, Seizures
- Trial name
- ERSET (NCT00040326)
- Testing
- anteromesial temporal resection, antiepileptic drugs
- Where
- 12 sites in United States
- Volunteers
- 200 people
- Sponsor
- University of California, Los Angeles
Birth Defects, Pregnancy Complications
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the…
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Trial name
- NCT00345475
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- UCB Pharma
Lennox-Gastaut Syndrome
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
OBJECTIVES: I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
- Trial name
- NCT00004776
- Testing
- topiramate
- Volunteers
- 10 people
- Sponsor
- National Center for Research Resources (NCRR)
Angelman Syndrome, Nervous System Diseases
Dietary Supplements for the Treatment of Angelman Syndrome
Angelman syndrome (AS) is a complex genetic disorder that affects the nervous system. The purpose of this study is to determine the effectiveness of certain dietary supplements in treating the symptoms of AS.
- Trial name
- NCT00348933
- Testing
- Betaine, Creatine, Metafolin
- Where
- 4 sites in United States
- Volunteers
- 90 people
- Sponsor
- University of California, San Diego
Lafora Disease
Natural History and Functional Status Study of Patients With Lafora Disease
A natural history and functional status study to characterize the clinical disease course in Lafora disease patients using standardized, quantitative evaluations and to identify useful biomarkers and clinical outcome measures for…
- Trial name
- NCT03876522
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 33 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Plagiocephaly, Nonsynostotic
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
- Trial name
- NCT06831513
- Testing
- Serkel 3D CRO
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Treatment Failure, Lethargy
RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia
Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000 children under five around the world. This means a loss of over 2,500 child lives every day, or over 100 every hour.
- Conditions
- Treatment Failure, Lethargy, Altered Mental Status, Convulsion, Non-Epileptic
- Trial name
- NCT03369093
- Testing
- Amoxicillin
- Where
- Bangladesh
- Volunteers
- 308 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Developmental and Epileptic Encephalopathies, Epileptic Spasms
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for…
- Conditions
- Developmental and Epileptic Encephalopathies, Epileptic Spasms, Genetic Epilepsy, Neonatal and Infant Epilepsy
- Trial name
- NCT06700811
- Testing
- Ketogenic diet
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Heather Olson
Lennox Gastaut Syndrome
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in…
- Trial name
- NCT03778424
- Testing
- Rufinamide
- Where
- 2 sites in Poland
- Sponsor
- Eisai Inc.
Gaucher's Disease
Effects of Enzyme Replacement in Gaucher's Disease
Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase.
- Trial name
- NCT00001289
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Tuberous Sclerosis Complex
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be…
- Trial name
- NCT02962414
- Testing
- everolimus
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Seizures, Encephalopathy
Novel Epidermal Recording and Detection of Seizures
For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity.
- Conditions
- Seizures, Encephalopathy, Asphyxiated Newborn
- Trial name
- NERDS (NCT02451618)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Sharp HealthCare
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
An Extended Access Program (EAP) for Perampanel
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time…
- Trial name
- NCT02307578
- Testing
- Perampanel
- Where
- 27 sites in Belgium, Chile and 8 more
- Sponsor
- Eisai Inc.
Dravet Syndrome, Lennox Gastaut Syndrome
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
- Conditions
- Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy
- Trial name
- NCT03936777
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 71 sites in United States, Australia and 12 more
- Volunteers
- 412 people
- Sponsor
- Zogenix, Inc.
Vaso-occlusive Crisis, Sickle Cell Disease
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS).
- Trial name
- ReVCVO (NCT04756375)
- Testing
- Virtual Reality, Usual Care
- Where
- France
- Volunteers
- 97 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris