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

Last updated: May 30, 2025
Sponsor: Northwell Health
Overall Status: Completed

Phase

1

Condition

Epilepsy (Pediatric)

Epilepsy

Treatment

Placebo

Epidiolex 100 mg/mL Oral Solution

Clinical Study ID

NCT04721691
20-0168
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, aged 2-17 years old

  4. In good general health as evidenced by medical history or diagnosed with ESES. "Goodhealth" in relation to this study is understood as stable without current seizuresrequiring immediate hospitalization.

  5. Ability to take oral medication and be willing to adhere to the Epidiolex/Placeboregimen

  6. For females of reproductive potential: use of highly effective contraception for atleast 1 month prior to screening and agreement to use such a method during studyparticipation and for an additional 1 month after the end of oral Epidiolexadministration

  7. For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner

Exclusion

Exclusion Criteria:An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Previous use of cannabidiol within 4 months.

  2. Pregnancy or lactation

  3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seedoil, 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

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
March 10, 2021
Estimated Completion Date:
January 17, 2024

Study Description

This study attempts to view the effect of Epidiolex on subjects with Electrical Status Epilepticus of Sleep (ESES). ESES can cause various types of seizures which can fluctuate during sleep. Similar studies have been conducted with Epidiolex with other seizure disorders such as Lennox-Gastaut syndrome (LGS) and Dravet Syndrome. Since there is no data available on the effect of Cannabidiol (CBD) on patients with ESES, this study hopes to fill that void. As such, patients that have been diagnosed with ESES will be eligible to participate in this study to ascertain whether or not Epidiolex can reduce the frequency or intensity of the seizures brought on by ESES during sleep.

Connect with a study center

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

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