COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-10
Study Completion:2024-01-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04721691

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Previous use of cannabidiol within 4 months.
  2. 2. Pregnancy or lactation
  3. 3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose
  4. 4. Febrile illness within 1 month of screening
  5. 5. Treatment with another investigational drug or other intervention within 6 months
  6. 6. Current smoker or tobacco use within 6 months

Contacts and Locations

Study Locations (Sites)

Northwell Health
Lake Success, New York, 11042
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-10
Study Completion Date2024-01-17

Study Record Updates

Study Start Date2021-03-10
Study Completion Date2024-01-17

Terms related to this study

Keywords Provided by Researchers

  • Neurology
  • Pediatric
  • ESES

Additional Relevant MeSH Terms

  • Electrical Status Epilepticus of Slow-Wave Sleep