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OpenTrials
Completed

NCT Number: NCT04721691

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

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.

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Key information

Conditions

Electrical Status Epilepticus of Slow-Wave Sleep

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northwell Health

Lake Success, New York, 11042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 2-17 years old
  • In good general health as evidenced by medical history or diagnosed with ESES. "Good health" in relation to this study is understood as stable without current seizures requiring immediate hospitalization.
  • Ability to take oral medication and be willing to adhere to the Epidiolex/Placebo regimen
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 month after the end of oral Epidiolex administration
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion criteria

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

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

Treatment and study plan

Epidiolex 100 mg/mL Oral Solution

Drug

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

Other

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

Primary outcomes

  1. Frequency of Spike Wave Index

    Time frame: Up to 20 weeks

    Assess the reduction in spike wave index by evaluating the differences in activity from the four 24-hour ambulatory EEGs each participant obtains while enrolled in this study

Secondary outcomes

  1. Likert Scale Assessment

    Time frame: Up to 20 weeks

    The secondary objective is to assess seizure counts and subjective behavior change on a 5 point Likert scale (1= no improvement, 2= some improvement, 3=moderate improvement, 4=significant improvement, 5=extreme improvement).

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Jazz Pharmaceuticals

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2021
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.