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

Description

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.

Conditions

Electrical Status Epilepticus of Slow-Wave Sleep

Study Overview

Study Details

Study overview

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.

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

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

Condition
Electrical Status Epilepticus of Slow-Wave Sleep
Intervention / Treatment

-

Contacts and Locations

Lake Success

Northwell Health, Lake Success, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Previous use of cannabidiol within 4 months.
  • 2. Pregnancy or lactation
  • 3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose
  • 4. Febrile illness within 1 month of screening
  • 5. Treatment with another investigational drug or other intervention within 6 months
  • 6. Current smoker or tobacco use within 6 months

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Study Record Dates

2025-04