Clinical trials: Infantile Epileptic Spasms Syndrome
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
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
Epilepsy, Localization-related Epilepsy
Epilepsy Phenome/Genome Project
The purpose of this study is to collect detailed information about the characteristics and genetics of a large number of individuals with epilepsy.
- Conditions
- Epilepsy, Localization-related Epilepsy, Infantile Spasms, Lennox-Gastaut Syndrome
- Trial name
- EPGP (NCT00552045)
- Where
- 25 sites in United States, Argentina and 1 more
- Volunteers
- 4,150 people
- Sponsor
- University of California, San Francisco
Epileptic Spasms
Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms
Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of children.
- Trial name
- NCT03807141
- Testing
- Modified Atkins diet
- Where
- India
- Volunteers
- 90 people
- Sponsor
- Lady Hardinge Medical College
Spasms, Infantile, Prednisolone
Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
The goal of this clinical trial is to learn if short courses (7 days) of oral prednisolone are as effective as longer courses (14 days) in treating Infantile Epileptic Spasms Syndrome (IESS) in infants.
- Trial name
- SLISS (NCT06838559)
- Testing
- Short-Duration Oral Prednisolone with Extended Tapering, Standard Oral Prednisolone Regimen with Tapering
- Where
- 7 sites in Sri Lanka
- Volunteers
- 182 people
- Sponsor
- University of Colombo
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
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
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
Infantile Spasms
Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy Neurology/ Child Neurology Society practice parameter update on the medical treatment of infantile spasms concluded…
- Trial name
- PREDVGB (NCT02299115)
- Testing
- Prednisolone, Vigabatrin
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
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
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
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
Ketogenic Diet, West Syndrome
Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall. The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are…
- Conditions
- Ketogenic Diet, West Syndrome, Infantile Spasm, ACTH
- Trial name
- NCT05279118
- Testing
- Ketogenic diet, ACTH
- Where
- 2 sites in India
- Volunteers
- 80 people
- Sponsor
- All India Institute of Medical Sciences
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
Infantile Spasms
Genetic Studies in Patients and Families With Infantile Spasms
Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic developmental consequences, is known in some patients to have many different genetic, metabolic and structural etiologies.
- Trial name
- NCT01723787
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Colorado, Denver
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
Infantile Spasms
Open-label Extension to Protocol 1042-0500
To allow open-label extension to patients who have completed Protocol 1042-0500
- Trial name
- NCT00442104
- Testing
- Ganaxolone
- Where
- 14 sites in United States
- Volunteers
- 54 people
- Sponsor
- Marinus Pharmaceuticals
West Syndrome
Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on electroencephalogram (EEG or brain wave test)…
- Trial name
- PREVENT-WS (NCT01367964)
- Testing
- adrenocorticotropin hormone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
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
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