An Open Label Study of FT218 in Subjects With Narcolepsy (NCT04451668) | Clinical Trial Compass
CompletedPhase 3
An Open Label Study of FT218 in Subjects With Narcolepsy
United States184 participantsStarted 2020-06-12
Plain-language summary
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
Who can participate
Age range16 Years
SexALL
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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…
What they're measuring
1
Incidence of treatment-related adverse events
Timeframe: 24 months
2
Incidence of clinically significant changes in vital signs
Timeframe: 24 months
3
Incidence of clinically significant changes in laboratory test results