Clinical trials: Neonatal Convulsions
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
Brain Malformation, Neuronal Migration Disorder
Human Epilepsy Genetics--Neuronal Migration Disorders Study
The purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.
- Conditions
- Brain Malformation, Neuronal Migration Disorder, Cognition Disorder, Epilepsy
- Trial name
- NCT00041600
- Where
- United States
- Volunteers
- 3,500 people
- Sponsor
- Harvard University Faculty of Medicine
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
Hypoxic Ischemic Encephalopathy (HIE)
Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen…
- Trial name
- SHINE (NCT07024771)
- Testing
- Automated Pupillometer
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- University of Calgary
Epilepsy
Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study
The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network …
- Trial name
- NCT05485649
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- University Health Network, Toronto
Tuberous Sclerosis Complex, Seizures
A Randomized Controlled 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 blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo.
- Trial name
- NCT02544763
- Testing
- GWP42003-P
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 224 people
- Sponsor
- Jazz Pharmaceuticals
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
Hypothyroidism, Global Developmental Delay
Register for Patients With Thyroid Hormone Resistance.
Thyroid hormones (TH) play a pivotal role in the development and function of the mammalian brain. Patients with impaired thyroid hormone transport into the brain tissue or in the case of defective local thyroid hormone receptor…
- Conditions
- Hypothyroidism, Global Developmental Delay, Intellectual Disability, Dystonia
- Trial name
- DEEPTYPE (NCT06566066)
- Testing
- no intervention
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Chronic Pain, Chronic Pain Syndrome
Outcomes Mandate National Integration With Cannabis as Medicine
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Chronic Pain Due to Injury, Chronic Pain Due to Trauma
- Trial name
- OMNI-Can (NCT03944447)
- Testing
- Cannabis, Medical, RYAH-Medtech Inhaler
- Where
- 17 sites in United States
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- OMNI Medical Services, LLC
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
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
Epilepsy
Herpes Virus-6 and Epilepsy
This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients.
- Trial name
- NCT00085683
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Neonatal Convulsions, Newborn Seizure Disorders
Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth…
- Conditions
- Neonatal Convulsions, Newborn Seizure Disorders, Seizures
- Trial name
- NCT07274410
- Testing
- Management of Neonatal Convulsions
- Volunteers
- 139 people
- Sponsor
- Assiut University
Plagiocephaly, Nonsynostotic
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
- Trial name
- NCT06831513
- Testing
- Serkel 3D CRO
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Neonatal Seizure
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based…
- Trial name
- NCT01224457
- Testing
- Phenobarbital
- Volunteers
- 52 people
- Sponsor
- Yonsei University
Seizures, Seizure Disorder
Etiology and Treatment of Neonatal Seizure
Genetic diagnosis for neonates suffering from epilepsy has important implications for treatment, prognosis, and development of precision medicine strategies.
- Conditions
- Seizures, Seizure Disorder, Seizure Newborn, Seizure Generalized
- Trial name
- NCT03822741
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Children's Hospital of Fudan University
Seizures, Epilepsy
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures.
- Trial name
- NCT01261416
- Testing
- levetiracetam
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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.
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Neonatal Seizures
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.
- Trial name
- NEOLEV2 (NCT01720667)
- Testing
- Intravenous levetiracetam, Intravenous phenobarbital
- Where
- United States
- Volunteers
- 280 people
- Sponsor
- Richard H. Haas