Epidiolex for treating seizures during sleep in children
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
This study is testing if Epidiolex can help reduce sleep-related seizures in children aged 2-17 who have a condition called ESES.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Lake Success, New York) |
| Trial ID | NCT04721691 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Epidiolex, a cannabidiol oral solution, in reducing seizures associated with Electrical Status Epilepticus of Sleep (ESES) in pediatric patients aged 2-17. It employs a double-blind, placebo-controlled crossover design to compare the effects of Epidiolex against a placebo. The study aims to fill a gap in existing research, as there is currently no data on the use of CBD for ESES, despite its previous success in other seizure disorders. Participants will be closely monitored to assess changes in seizure frequency and intensity during sleep.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-17 diagnosed with ESES who are in good general health and can adhere to the treatment regimen.
Not a fit: Patients with ongoing seizures requiring immediate hospitalization or those not diagnosed with ESES may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce seizure activity in children suffering from ESES, improving their quality of life.
How similar studies have performed: Previous studies have shown success with Epidiolex in treating other seizure disorders, indicating potential for efficacy in ESES, although this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lake Success, New York
- Northwell Health — Lake Success, New York, United States (Recruiting)
Study contacts
- Study coordinator: Sanjeev V. Kothare, MD
- Email: skothare@northwell.edu
- Phone: (516) 465-5255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.