Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT02983695
Eligibility Criteria:
Inclusion Criteria:
* Drug resistant epilepsy due to Dravet syndrome
* Must have clinically apparent seizures
* Must be able to tolerate administration of medication orally or enterally via gastrostomy tube
* Was never on Cannabinoid therapy or have not been treated with Cannabinoid products for at least last 60 days (confirmed by negative urine test for Tetrahydrocannabidiol (THC), only for those who had been treated with CBD).
Exclusion Criteria:
* Co-morbid liver or renal disease
* Without clinically-apparent seizures
* Currently taking any Cannabinoid products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT02983695
Study Brief:
Protocol Section:
NCT02983695