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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT04451668
Eligibility Criteria:
Inclusion Criteria:
* Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218
* Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate
* Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)
* Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014)
* Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.
Exclusion Criteria:
* Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8
* Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.)
* A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04451668
Study Brief:
Protocol Section:
NCT04451668