Clinical trials: Epileptic Spasm
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
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
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
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
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
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
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 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
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
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