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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06262594
Eligibility Criteria:
Inclusion Criteria:
* Sleep-related focal epilepsy
* Contraception
Exclusion Criteria:
* Changes in antiseizure medication 1 month before study protocol or during study protocol
* Concomitant medications per SUNRISE1
* Individuals with hepatic impairment
* Female participants who are pregnant or breastfeeding
* Individuals with compromised respiratory function
* Individuals with a history of complex sleep-related behaviour
* Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
* Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
* Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
* Individuals with a diagnosis of narcolepsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06262594
Study Brief:
Protocol Section:
NCT06262594