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

Launched by NORTHWELL HEALTH · Jan 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Epidiolex in treating a condition known as Electrical Status Epilepticus of Sleep (ESES). ESES is a rare type of seizure disorder that occurs during sleep, and it can be challenging to manage with standard treatments. The trial aims to see if Epidiolex, which contains cannabidiol (a compound found in cannabis), can help reduce the frequency and severity of these seizures.

To participate in this study, children and teenagers aged 2 to 17 who have been diagnosed with ESES may be eligible. Participants must be in good general health, able to take oral medicine, and willing to follow the study procedures for its duration. They will be randomly assigned to receive either Epidiolex or a placebo (a non-active treatment) in a way that neither they nor the researchers know which one they are receiving at first. This helps ensure that the results are unbiased. If you or someone you know fits these criteria, this trial could offer a new treatment option for managing ESES.

Gender

ALL

Eligibility criteria

• 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