Clinical trials: Neonatal Seizures
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.
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)
EEC
Diagnostic and Prognostic Criteria of EEG in Neonatal Convulsions at Assiut University Children Hospital
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital
- Trial name
- NCT06106425
- Testing
- EEG
- Volunteers
- 100 people
- Sponsor
- Assiut University
Seizures, Lennox Gastaut Syndrome
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects…
- Trial name
- NCT05219617
- Testing
- Carisbamate
- Where
- 71 sites in United States, Argentina and 14 more
- Volunteers
- 252 people
- Sponsor
- SK Life Science, Inc.
Lennox Gastaut Syndrome
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with…
- Trial name
- NCT05066217
- Testing
- Clemizole HCl
- Where
- 71 sites in United States, China and 8 more
- Volunteers
- 260 people
- Sponsor
- Epygenix
Headache, Tumor
Dexmedetomidine and Propofol for Pediatric MRI Sedation
The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia…
- Conditions
- Headache, Tumor, Seizure Disorder, Neurofibromatoses
- Trial name
- NCT03513757
- Testing
- propofol, Dexmedetomidine, Glycopyrrolate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Hypoxic Ischemic Encephalopathy, Neonatal Convulsions
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.
- Conditions
- Hypoxic Ischemic Encephalopathy, Neonatal Convulsions, Subgaleal Hematoma
- Trial name
- SVEA (NCT03071783)
- Testing
- Vacuum extraction intelligent system
- Where
- Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska Institutet
Neonatal Seizure, Neonatal Encephalopathy
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly…
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Trial name
- NEOLEV3 (NCT05610085)
- Testing
- Levetiracetam Injection, Phenobarbital Sodium Injection
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 133 people
- Sponsor
- University of California, San Diego
Neonatal Convulsion
Phenobarbital Versus Levetiracetam Neonatal Convulsion
If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not…
- Trial name
- NCT06181383
- Volunteers
- 42 people
- Sponsor
- Assiut University
STXBP1 Encephalopathy with Epilepsy
Natural History Study in Pediatric Patients with STXBP1 Encephalopathy with Epilepsy
This is a prospective, non-interventional, longitudinal study designed to characterize the natural history of STXBP1 related encephalopathy with epilepsy, in participants ≤ <5 years of age.
- Trial name
- NCT05462054
- Sponsor
- Capsida Biotherapeutics, Inc.
Lennox Gastaut Syndrome
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome is a serious and rare form of epilepsy that begins in infancy and early childhood. Seizures and their consequences need medical attention, emergency encounters, and hospitalizations.
- Trial name
- SOM-L (NCT05374824)
- Where
- 4 sites in United States
- Volunteers
- 4,680 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Electroencephalographic Neonatal Seizures
A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures
The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the…
- Trial name
- NCT03325439
- Testing
- Brivaracetam (BRV) intravenous (iv), Brivaracetam (BRV) oral
- Where
- 12 sites in Belgium, Czechia and 5 more
- Volunteers
- 9 people
- Sponsor
- UCB Biopharma SRL
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
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
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
Seizures
Epidemiology Study on Neonatal Seizure
A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose.
- Trial name
- NCT02552511
- Where
- China
- Volunteers
- 1,400 people
- Sponsor
- Children's Hospital of Fudan University
Intracranial Abscess
Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With IA
This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.
- Trial name
- NCT07051382
- Testing
- Transcranial Sonographic Examination (Cranial Ultrasound)
- Where
- Pakistan
- Volunteers
- 122 people
- Sponsor
- Superior University
Tuberous Sclerosis Complex
Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to…
- Trial name
- NCT02849457
- Testing
- Early Vigabatrin
- Where
- 13 sites in United States
- Volunteers
- 84 people
- Sponsor
- Martina Bebin
Tuberous Sclerosis Complex
Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC
To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients that will develop infantile spasms/epilepsy in the near future and thus are appropriate candidates for an antiepileptogenic drug trial.
- Trial name
- NCT01767779
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
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