Clinical trials: Neonatal Convulsions
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
Epilepsy, Lennox Gastaut Syndrome
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
- Trial name
- GWPCARE3 (NCT02224560)
- Testing
- GWP42003-P
- Where
- 29 sites in United States, France and 2 more
- Volunteers
- 225 people
- Sponsor
- Jazz Pharmaceuticals
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic…
- Trial name
- NCT06792500
- Testing
- Glycerol Tributyrate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- George Washington University
Sepsis, Asthma
Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training
The aim of the proposed study is to determine if specific training in management of general, obstetric, neonatal and pediatric emergencies results in a change in practice of doctors working in emergency departments of public…
- Conditions
- Sepsis, Asthma, Heart Failure, Seizure
- Trial name
- NCT00880204
- Testing
- ESS-EMCH training
- Where
- 2 sites in Pakistan
- Volunteers
- 36 people
- Sponsor
- Child Advocacy International
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhage
- Trial name
- NSR-GENE (NCT05361070)
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of California, San Francisco
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
EEG, Neonatology
An Observational Study of the NeuroBell EEG Monitor
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
- Conditions
- EEG, Neonatology, Seizure, Neurology
- Trial name
- NCT07508670
- Testing
- NeuroBell EEG Monitor
- Where
- Ireland
- Volunteers
- 17 people
- Sponsor
- University College Cork
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Epilepsy, Lennox-Gastaut Syndrome
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).
- Trial name
- GWPCARE4 (NCT02224690)
- Testing
- GWP42003-P 20 mg/kg/day Dose
- Where
- 24 sites in United States, Netherlands and 1 more
- Volunteers
- 171 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsy; Seizure, Neuromuscular Diseases
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family…
- Conditions
- Epilepsy; Seizure, Neuromuscular Diseases, Brain Malformation, Intellectual Disability
- Trial name
- NCGENES2 (NCT03548779)
- Testing
- Pre-visit prep, usual care + exome seq
- Where
- 3 sites in United States
- Volunteers
- 548 people
- Sponsor
- University of North Carolina, Chapel Hill
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
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
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
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of…
- Trial name
- CANN-SWITCH (NCT06924827)
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Elizabeth Donner
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
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
Neonatal Seizure, Epilepsy
Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations
Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns).
- Trial name
- NCT06308185
- Testing
- observational study
- Where
- Italy
- Volunteers
- 140 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE.
- Trial name
- NCT06719141
- Testing
- LP352
- Where
- 116 sites in United States, Australia and 15 more
- Volunteers
- 367 people
- Sponsor
- Longboard Pharmaceuticals