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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04923594
Eligibility Criteria:
Key Inclusion Criteria:
* Males and females between 18 and 65 years of age, inclusive
* Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Body mass index from 18 to 40 kg/m2, inclusive
* Consent to use a medically acceptable method of contraception
* Willing and able to provide written informed consent
Key Exclusion Criteria:
* Female subjects who are pregnant, nursing, or lactating
* Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
* History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
* Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
* Use of any medications that could affect the evaluation of cataplexy
* Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04923594
Study Brief:
Protocol Section:
NCT04923594