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Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
Sponsor: Northwell Health
Summary
This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2021-03-10
Completion Date
2024-01-17
Last Updated
2026-08-28
Healthy Volunteers
No
Interventions
Epidiolex 100 mg/mL Oral Solution
Epidiolex is a schedule 5 controlled substance that is a colorless to yellow oral liquid solution that is prepackaged into 100mL vials with 5mL syringes for use. It is typically used for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet Syndrome in patients 2 years of age and older.
Placebo
Placebo is composed of dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.
Locations (1)
Northwell Health
Lake Success, New York, United States