Clinical trials: Neonatal Seizure
Neonatal Seizures
EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy
The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full or continuous electroencephalography (cEEG) is superior to amplitude-integrated electroencephalography (aEEG) in the…
- Trial name
- EAGLET (NCT05079971)
- Testing
- Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology
- Where
- United Kingdom
- Volunteers
- 140 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Seizures, Brain Diseases
A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection
The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.
- Conditions
- Seizures, Brain Diseases, Central Nervous System Diseases, Epilepsy
- Trial name
- ANSeR (NCT02431780)
- Testing
- ANSeR Software System
- Where
- 8 sites in Ireland, Netherlands and 2 more
- Volunteers
- 264 people
- Sponsor
- University College Cork
Neonatal Seizure
Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital Sodium Injection, United States Pharmacopeia, (USP), in participants who have suffered from a…
- Trial name
- NCT03602118
- Testing
- Phenobarbital Sodium Injection
- Sponsor
- PharPoint Research, Inc.
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
Citrate Transporter Deficiency, Epilepsy
SLC13A5 Deficiency Natural History Study - United States Only
SLC13A5 deficiency (Citrate Transporter Disorder, EIEE 25) is a rare genetic disorder with neurodevelopmental delays and seizure onset in the first few days of life.
- Conditions
- Citrate Transporter Deficiency, Epilepsy, Rare Diseases, Movement Disorders
- Trial name
- NCT06144957
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- TESS Research Foundation
Malformations, Multiple Abnormalies
Phenotype and Etiology of Pallister-Hall Syndrome
We aim to delineate the range of severity, natural history, molecular etiology, and pathophysiology of Pallister-Hall syndrome (PHS), Greig cephalopolysyndactyly syndrome (GCPS), McKusick-Kaufman syndrome (MKS), Bardet-Biedl…
- Conditions
- Malformations, Multiple Abnormalies, Polydactyly
- Trial name
- NCT00001404
- Where
- 4 sites in United States, Turkey (Türkiye)
- Volunteers
- 1,170 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Neonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy
Treatment of Seizures in Neonate With HIE
Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE
- Trial name
- HIE (NCT07284498)
- Testing
- Phenobarbital, Levetiracetam
- Where
- 2 sites in Egypt
- Volunteers
- 66 people
- Sponsor
- Mansoura University
Epilepsy, Epilepsy, Generalized
Clobazam in Patients With Lennox-Gastaut Syndrome
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut…
- Conditions
- Epilepsy, Epilepsy, Generalized, Seizures
- Trial name
- NCT00518713
- Testing
- Clobazam Low Dose, Clobazam Medium Dose, Clobazam High Dose
- Where
- 53 sites in United States, Australia and 3 more
- Volunteers
- 238 people
- Sponsor
- Lundbeck LLC
Lennox-Gastaut Syndrome
Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. The tonic seizure occur mostly at night.
- Trial name
- NCT01370486
- Testing
- melatonin
- Where
- Switzerland
- Sponsor
- Institution de Lavigny
Seizures
Dosing of Levetiracetam (Keppra) in Neonates
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures.
- Trial name
- NCT01239212
- Testing
- levetiracetam
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Epilepsy, Seizures
A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome
The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of…
- Trial name
- NCT00236756
- Testing
- topiramate
- Volunteers
- 100 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Lennox-Gastaut Syndrome
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3…
- Trial name
- NCT02318537
- Testing
- Cannabidiol Oral Solution
- Sponsor
- INSYS Therapeutics Inc
Neonatal Seizures
Levetiracetam Treatment of Neonatal Seizures
Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment…
- Trial name
- NCT02550028
- Testing
- Oral levetiracetam, Intravenous phenobarbital
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Tuberous Sclerosis Complex
Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC
The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
- Trial name
- NCT05059327
- Where
- 27 sites in United States, India and 6 more
- Volunteers
- 61 people
- Sponsor
- Noema Pharma AG
Seizures, Encephalopathy
The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy
This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG with a "Clinical Seizure Treatment…
- Trial name
- NCT01027715
- Testing
- EEG monitoring and treatment of EEG seizures
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Washington University School of Medicine
Hyperhomocysteinemia, Thrombotic, Cbs-Related, Ischemic Stroke
Methylenetetrahydrofolate Reductase Deficiency in Ischemic Stroke
Adult onset epileptic seizures is rare and often associated with metabolic disorders, drugs and intracranial pathologies such as ischemia, hemorrhage or space-occupying lesions.
- Conditions
- Hyperhomocysteinemia, Thrombotic, Cbs-Related, Ischemic Stroke, Epilepsy
- Trial name
- NCT04287881
- Testing
- Methylenetetrahydrofolate reductase (MTHFR) deficiency
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 32 people
- Sponsor
- Istanbul Medeniyet University
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
Neonatal Encephalopathy
Remote EEG Device for Identification of Risk for Neonatal Seizures
The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.
- Trial name
- NCT05239585
- Testing
- Epilog device
- Where
- United States
- Sponsor
- Mayo Clinic
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)