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

Electrical Status Epilepticus of Slow-Wave Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721691
• Other study ID #: 20-0168
• Status: Recruiting
• Phase: Phase 1
• Start date: March 10, 2021
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Northwell Health
• Contact: Sanjeev V. Kothare, MD
• Phone: (516) 465-5255
• Email: skothare[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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 the duration 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. "Good health" in relation to this study is understood as stable without current seizures requiring immediate hospitalization.

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

6. 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

7. 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:

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

Related Conditions & MeSH terms

• Electrical Status Epilepticus of Slow-Wave Sleep
• Status Epilepticus

Intervention

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

Country	Name	City	State
United States	Northwell Health	Lake Success	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Spike Wave Index	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	Up to 20 weeks
Secondary	Likert Scale Assessment	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).	Up to 20 weeks