Clinical trials: Infantile Spasm
Infantile Spasms
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record.
- Trial name
- NCT02954887
- Testing
- GWP42003-P
- Where
- 7 sites in United States, Poland
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
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)
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
West Syndrome
Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation
Currently, no literature is available regarding degree of cortical excitability and its correlation with various epileptic syndromes and disorders such as West Syndrome in pediatric age group.
- Trial name
- NCT06201897
- Testing
- ACTH/Oral Steroids
- Where
- India
- Volunteers
- 40 people
- Sponsor
- All India Institute of Medical Sciences
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, Refractory Complex Partial Seizures in Adults
Sabril Patient Registry
The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.
- Trial name
- NCT01073579
- Testing
- Sabril®
- Volunteers
- 9,423 people
- Sponsor
- Lundbeck LLC
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 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
Infantile Spasms
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending…
- Trial name
- NCT00441896
- Testing
- Ganaxolone
- Where
- 15 sites in United States
- Volunteers
- 57 people
- Sponsor
- Marinus Pharmaceuticals
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
Tricaprilin Infantile Spasms Pilot Study
The purpose of this study is to assess the safety, tolerability, and efficacy of tricaprilin in subjects with infantile spasms. This is a single-arm, open-label, pilot study in up to 10 subjects with infantile spasms.
- Trial name
- NCT04727970
- Testing
- Tricaprilin
- Where
- 4 sites in Australia, Singapore
- Volunteers
- 8 people
- Sponsor
- Cerecin
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, West Syndrome
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes.
- Trial name
- NCT04302116
- Testing
- Combination therapy with vigabatrin and prednisolone, Vigabatrin Tablets
- Where
- Thailand
- Volunteers
- 250 people
- Sponsor
- Kullasate Sakpichaisakul
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
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
Infantile Spasms
Use of the Modified Atkins Diet in Infantile Spasms
Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children.
- Trial name
- ADIS (NCT01006811)
- Testing
- modified Atkins diet
- Where
- India
- Volunteers
- 15 people
- Sponsor
- All India Institute of Medical Sciences
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
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)
Epilepsy, West Syndrome
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during…
- Conditions
- Epilepsy, West Syndrome, Dravet Syndrome
- Trial name
- EPIRARE (NCT05126914)
- Where
- 11 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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