Clinical trials: Infantile Spasm
Infantile Spasms
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record.
- Trial name
- NCT02953548
- Testing
- GWP42003-P
- Where
- 8 sites in United States, Poland
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
Refractory Infantile Spasms
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.
- Trial name
- NCT03976076
- Testing
- JBPOS0101
- Where
- 23 sites in United States, South Korea
- Volunteers
- 16 people
- Sponsor
- Bio-Pharm Solutions Co., Ltd.
Infantile Spasms
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.
- Trial name
- NCT01413711
- Testing
- Vigabatrin
- Sponsor
- Lundbeck LLC
Spasms, Infantile, Epilepsy
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II.
- Trial name
- NCT00004758
- Testing
- carbamazepine, corticotropin, nitrazepam
- Volunteers
- 30 people
- Sponsor
- National Center for Research Resources (NCRR)
Infantile Spasms
Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy
Infantile spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult.
- Trial name
- NCT01549288
- Testing
- modified Atkins diet, no dietetic input
- Where
- India
- Sponsor
- Lady Hardinge Medical College
Infantile Spasms
Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment.
- Trial name
- NCT06315829
- Testing
- Spasm Vision
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Johns Hopkins University
Spasms, Infantile
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS.
- Trial name
- NCT02551731
- Testing
- Cannabidiol Oral Solution
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- INSYS Therapeutics Inc
Infantile Spasms, Infantile Epileptic Spasms Syndrome
A Study to Prevent Infantile Spasms Relapse
After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy.
- Conditions
- Infantile Spasms, Infantile Epileptic Spasms Syndrome, West Syndrome
- Trial name
- NCT06819670
- Testing
- Prednisolone, Famotidine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, Los Angeles
Epileptic Spasms, Failed Hormonal Therapy
Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
This study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified Atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized…
- Trial name
- TOPAMAD (NCT05958160)
- Testing
- Modified Atkins diet, Topiramate
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Lady Hardinge Medical College
Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG).
- Conditions
- Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
- Trial name
- IBIS (NCT07585643)
- Testing
- Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.
- Where
- 2 sites in Australia, Brazil
- Volunteers
- 40 people
- Sponsor
- Telethon Kids Institute
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
Infantile Spasm
Treatment of Refractory Infantile Spasms With Fenfluramine
This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability.
- Trial name
- NCT04289467
- Testing
- Fenfluramine
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Orange County
Epilepsy
A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant…
- Trial name
- SPASMES-NIRS (NCT02899832)
- Testing
- NIRS
- Where
- 2 sites in France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Infantile Spasm
Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms
Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directed over the past years to…
- Trial name
- MPIV (NCT03876444)
- Testing
- Intravenous Methylprednisolone, Oral Pednisolone
- Where
- India
- Volunteers
- 128 people
- Sponsor
- Suvasini Sharma
Epileptic Encephalopathy
Cannabidiol in Children With Refractory Epileptic Encephalopathy
This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy.
- Trial name
- CARE-E (NCT03024827)
- Testing
- CanniMed® 1:20
- Where
- 4 sites in Canada
- Volunteers
- 20 people
- Sponsor
- University of Saskatchewan
Infantile Spasms, West Syndrome
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice.
- Trial name
- NCT01575639
- Testing
- Oral prednisolone
- Where
- India
- Volunteers
- 63 people
- Sponsor
- Lady Hardinge Medical College
Infantile Spasms
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug.
- Trial name
- SoluWest (NCT02220114)
- Testing
- Vigabatrin: Vigabatrin new ST formulation then Sabril®
- Where
- 12 sites in France
- Volunteers
- 38 people
- Sponsor
- Orphelia Pharma
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
Generalized Epilepsy, Infantile Spasms
Metabolic Abnormalities in Children With Epilepsy
This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain.
- Conditions
- Generalized Epilepsy, Infantile Spasms, Metabolic Disease, Partial Epilepsy
- Trial name
- NCT00001325
- Testing
- 18 FDG
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Infantile Colic, Infantile Spasm
The Effect of Spa and Massage on Babies on Colic Symptoms
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications.
- Trial name
- NCT05538936
- Testing
- Baby SPA, Massage
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yuzuncu Yil University