Clinical trials: Infantile Epileptic Spasms Syndrome
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)
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 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, 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
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
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
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
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
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.
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
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
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
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, 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 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
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
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
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 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