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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT03865732
Eligibility Criteria:
Inclusion Criteria:
* Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant
* Failure to control seizures despite 2 or more anti-seizure medications
* 12 seizures over a 12-week period of primary seizure types prior to screening
* On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet should be unchanged for 3 months prior to screening)
Exclusion Criteria:
* Previous exposure to ganaxolone
* \> 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening
* Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted
* Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited during the double-blind phase
* Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT03865732
Study Brief:
Protocol Section:
NCT03865732