Clinical trials: Infantile Spasms
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.
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
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 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
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
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
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.
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
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 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)
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, 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
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
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
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
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
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
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
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