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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05059327
Eligibility Criteria:
Inclusion Criteria (summary):
* Ability and willingness to provide informed assent or written consent or consent from their legal representative.
* Fluency in the language of the study staff
* Age 5 to 30 years at study entry
* A documented history of TSC
* Refractory seizure history
* Currently receiving one or more anti-epileptic drugs (AEDs)
* Stable medications or interventions for epilepsy
* Willingness to complete Patient Reported Outcome assessments
* For female patients of childbearing potential:
1. Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period.
2. Willingness to use contraception.
Exclusion Criteria (summary):
* Neurologic disease other than TSC
* Recent anoxic episode
* Patient weight below 15kg
* Clinically significant unstable medical condition(s)
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
30 Years
Study:
NCT05059327
Study Brief:
Protocol Section:
NCT05059327