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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04289467
Eligibility Criteria:
Inclusion Criteria:
* Children ages 12 to 36 months, inclusive
* Clinical diagnosis of infantile spasms
* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
Exclusion Criteria:
* Significant preexisting cardiovascular disease
* Exposure to any cannabinoid product within 14 days of screening
* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
* Implantation of a vagal nerve simulator within 14 days of screening
* Initiation and maintenance of the ketogenic diet within 3 months of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
36 Months
Study:
NCT04289467
Study Brief:
Protocol Section:
NCT04289467