Clinical trials: Infantile Spasm
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
Spasms, Infantile
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms
The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).
- Trial name
- NCT05128344
- Testing
- AMZ002 injectable solution, 0.5mg/mL, Vigabatrin, oral
- Where
- 41 sites in United States, Argentina and 6 more
- Sponsor
- Amzell
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
Infantile Spasms, West Syndrome
Molecular Genetics in Infantile Spasms
Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters with an onset in the first year of life.
- Trial name
- NCT02885389
- Volunteers
- 41 people
- Sponsor
- Hospices Civils de Lyon
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
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
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)
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
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
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
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 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
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
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
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 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
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
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
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 (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.