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COMPLETED
NCT04721691
PHASE1

Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

Sponsor: Northwell Health

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

Placebo

Placebo is composed of dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Locations (1)

Northwell Health

Lake Success, New York, United States