Clinical trials: Infantile Epileptic Spasms Syndrome
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
Infantile Spasms
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.
- Trial name
- NCT00968136
- Sponsor
- Yonsei University
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
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
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
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 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
Infantile Spasm
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment…
- Trial name
- NCT03421496
- Testing
- Cannabidiol Oral Solution, Vigabatrin
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Radius Pharmaceuticals, Inc.
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
Infantile Spasm
Characterization by Automated System on Infantile Spasmes
Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms.
- Trial name
- REASSESS (NCT06266234)
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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 Spasms
Addition of Pyridoxine to Prednisolone in Infantile Spasms
Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia.
- Trial name
- NCT01828437
- Testing
- Pyridoxine plus prednisolone, Prednisolone
- Where
- India
- Volunteers
- 62 people
- 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
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
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 Spasm
A Novel Approach to Infantile Spasms
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension…
- Trial name
- NCT03347526
- Testing
- Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin, Vigabatrin
- Where
- 14 sites in United States
- Volunteers
- 394 people
- Sponsor
- University of Colorado, Denver
Infantile Spasms
Evaluation of Neuroinflammation in Children With Infantile Spasms
The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK…
- Trial name
- NCT02092883
- Testing
- ACTH
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Wayne State University
Infantile Spasms, Non-Intractable
Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology
This study plans to learn more about how the use of new telemedicine technology can help with parental stress, costs, and overall satisfaction in care.
- Trial name
- NCT04086992
- Testing
- Remote monitoring
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Colorado, Denver
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
- Conditions
- CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure, Epileptic Spasm, Refractory Seizures
- Trial name
- GEMZ (NCT05064878)
- Testing
- Fenfluramine
- Where
- 46 sites in United States, Austria and 12 more
- Volunteers
- 87 people
- Sponsor
- Zogenix, Inc.
Infantile Spasms (IS)
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
- Trial name
- NCT02829827
- Testing
- Radiprodil
- Where
- France
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma S.P.R.L.