Status:
COMPLETED
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Jazz Pharmaceuticals
Conditions:
Electrical Status Epilepticus of Slow-Wave Sleep
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief 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 ...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04721691
Start Date
March 10 2021
End Date
January 17 2024
Last Update
June 4 2025
Active Locations (1)
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1
Northwell Health
Lake Success, New York, United States, 11042