Clinical trials: Neonatal Convulsions
Lennox Gastaut Syndrome
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with…
- Trial name
- NCT03355209
- Testing
- ZX008 0.2 or 0.8 mg/kg/day
- Where
- 72 sites in United States, Australia and 12 more
- Volunteers
- 296 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, 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
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
Urea Cycle Disorders, Organic Acidemias
Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants
This is a pilot study which will test the safety and feasibility of hypothermia treatment as adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates versus conventional treatment (dialysis…
- Trial name
- NCT01624311
- Testing
- Therapeutic Hypothermia, Standard of Care Therapy
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Uta Lichter-Konecki
Cavernous Malformation, Cerebral, Cavernous Angioma
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate…
- Conditions
- Cavernous Malformation, Cerebral, Cavernous Angioma, Cavernous Hemangioma, Cavernous Hemangioma of Brain
- Trial name
- CRESS (NCT04076449)
- Where
- 2 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- yuanli Zhao
Neonatal Seizures
Prophylactic Phenobarbital After Neonatal Seizures
The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful.
- Trial name
- PROPHENO (NCT01089504)
- Testing
- phenobarbital
- Where
- 18 sites in United States
- Volunteers
- 13 people
- Sponsor
- University of Rochester
Tuberous Sclerosis Complex, Seizures
An Open-label Extension 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 open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P.
- Trial name
- NCT02544750
- Testing
- GWP42003-P
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
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.
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
Neonatal Seizure
What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
The investigators aimed to determine the factors for ceasing anti-seizure medication in infants who experienced seizures during the neonatal period.
- Trial name
- NCT06211192
- Testing
- retrospective data collection
- Where
- Turkey (Türkiye)
- Volunteers
- 158 people
- Sponsor
- Balikesir University
Tuberous Sclerosis Complex, Epilepsy
Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy (RESTOR-1)
This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC).
- Trial name
- RESTOR-1 (NCT07680322)
- Testing
- AV078
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- Aeovian Pharmaceuticals, Inc.
Epileptic Seizure, Intracranial Tumor
Our Anesthesia Experience During MRI Scan
In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study.
- Conditions
- Epileptic Seizure, Intracranial Tumor, Intracranial Hypertension, Intracranial Aneurysm
- Trial name
- NCT03123302
- Where
- Turkey (Türkiye)
- Volunteers
- 977 people
- Sponsor
- Akdeniz University
MELAS Syndrome
Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome
Patients with the MELAS syndrome experience devastating mental impairment. This study will evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.
- Trial name
- NCT00068913
- Testing
- Dichloroacetate
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed…
- Trial name
- NCT06908226
- Testing
- LP352
- Where
- 88 sites in United States, Australia and 15 more
- Volunteers
- 324 people
- Sponsor
- Longboard Pharmaceuticals
Tuberous Sclerosis Complex, Aspirin
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex
There had been much evidence in aspirin controlling tumorous conditions conducted by basic researches, especially through mammilian target of rapamycin (mTOR) pathway.
- Conditions
- Tuberous Sclerosis Complex, Aspirin, Epilepsy, Cognitive Decline
- Trial name
- NCT03356769
- Testing
- Aspirin, AED
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Peking Union Medical College Hospital
Neonatal Seizure
Neonatal Seizures in NICU of Assuit University Children's Hospital
A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.
- Trial name
- NCT05257889
- Testing
- blood and CSF studies + neuroimaging studies
- Volunteers
- 554 people
- Sponsor
- Assiut University
Prematurity, Neonatal Encephalopathy
Evaluating the NeoTree in Malawi and Zimbabwe
Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor.
- Conditions
- Prematurity, Neonatal Encephalopathy, Neonatal Sepsis, Neonatal Death
- Trial name
- NCT05127070
- Testing
- Neotree
- Where
- 5 sites in Malawi, Zimbabwe
- Volunteers
- 19,000 people
- Sponsor
- University College, London
Lennox Gastaut Syndrome, Dravet Syndrome
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics.
- Conditions
- Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
- Trial name
- EpiTALY (NCT05485831)
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- 18 sites in Italy
- Volunteers
- 111 people
- Sponsor
- Jazz Pharmaceuticals
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
Seizures
Pilot Study of Bumetanide for Newborn Seizures
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications…
- Trial name
- NCT00830531
- Testing
- Bumetanide
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Soul, Janet , M.D.