Clinical trials: Neonatal Convulsions
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
Neonatal Seizures
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam.
- Trial name
- LEVNEONAT-1 (NCT02229123)
- Testing
- Intravenous Levetiracetam
- Where
- 8 sites in France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Tours
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
Seizures, Seizure Disorder
A Cohort Study on the Prognosis of Neonatal KCNQ2 Gene-associated Epileptic Encephalopathy
The researchers hope to explore the etiological distribution and influencing factors of KCNQ2-related neonatal convulsions or refractory epileptic encephalopathy, and to improve the level of assessment, identification…
- Conditions
- Seizures, Seizure Disorder, Seizure Newborn, Seizures, Generalized
- Trial name
- NCT03934268
- Testing
- KCNQ2
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Children's Hospital of Fudan University
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Neonatal Seizures
NEMO1:NEonatal Seizure Using Medication Off-patent
NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide.
- Trial name
- NEMO1 (NCT01434225)
- Testing
- Bumetanide
- Where
- 7 sites in Ireland, Netherlands and 2 more
- Volunteers
- 14 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Brain Injury, Seizures
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
- Conditions
- Brain Injury, Seizures, Cerebral Palsy
- Trial name
- BrainZ (NCT00516334)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Brigham and Women's Hospital
Seizures Newborn, Brain Injuries
Newborn Brain Test (NBT)
The aim of the overall project is to develop the Newborn Brain Test (NBT), a novel platform to detect abnormal brain activity in infants at birth through an automated AI assessment.
- Trial name
- NBT (NCT06580834)
- Testing
- Cergenx Wave
- Where
- Ireland
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Professor Geraldine Boylan
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
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
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.
Autosomal Dominant Hypocalcemia (ADH)
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
- Trial name
- CALIBRATE (NCT05680818)
- Testing
- Encaleret, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 67 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
Seizures, Epilepsy
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.
- Trial name
- NCT00297349
- Testing
- Topiramate
- Volunteers
- 153 people
- Sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
Neonatal Seizures
ANSeR- The Algorithm for Neonatal Seizure Recognition Study
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR
- Trial name
- ANSeR (NCT02160171)
- Testing
- Algorithm for Neonatal Seizure Recognition
- Where
- 6 sites in Ireland, Netherlands and 2 more
- Volunteers
- 240 people
- Sponsor
- University College Cork
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
Mitochondrial Diseases, Drug Resistant Epilepsy
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase.
- Conditions
- Mitochondrial Diseases, Drug Resistant Epilepsy, Leigh Disease, Leigh Syndrome
- Trial name
- MIT-E (NCT04378075)
- Testing
- Vatiquinone
- Where
- 27 sites in United States, Canada and 7 more
- Volunteers
- 68 people
- Sponsor
- PTC Therapeutics
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.
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry - Developmental Functional EValuation
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages
- Trial name
- NSR-DEV (NCT04337697)
- Where
- 9 sites in United States
- Volunteers
- 188 people
- Sponsor
- University of California, San Francisco
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
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.