Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-03-31

Brief Summary

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This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.

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Detailed Description

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Conditions

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Idiopathic Hypersomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

For the double-blind, randomized withdrawal portion of the study, the subject and all members of the study team will remain blinded to treatment assignment.

Study Groups

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FT218

FT218 at stable dose (selected during earlier titration) administered orally once nightly

Group Type EXPERIMENTAL

FT218

Intervention Type DRUG

Sodium oxybate for extended-release oral suspension

Placebo

Placebo equivalent administered orally once nightly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matched placebo equivalent for oral suspension

Interventions

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FT218

Sodium oxybate for extended-release oral suspension

Intervention Type DRUG

Placebo

Matched placebo equivalent for oral suspension

Intervention Type OTHER

Other Intervention Names

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LUMRYZ

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of idiopathic hypersomnia
* Total ESS score at Screening \> 11 if not on prior oxybate
* Average nightly total sleep time of \> 7 hours
* May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain stable until the double-blind, randomized withdrawal visit
* Females of childbearing potential must use highly effective contraception for 2 months prior to Baseline, throughout the study, and for 30 days after the last dose of study drug
* Males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug
* Willing and able to provide informed consent and comply with the requirements of the study

Exclusion Criteria

* Pregnant, nursing or lactating females
* Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
* Untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria
* Clinically significant parasomnias
* History or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment
* History or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
* Ongoing or past (within 1 year) major depressive episode
* At risk for suicide or history of suicide attempt
* If not on oxybate at Screening, treatment or planned treatment with any central nervous system (CNS) sedating agents during study
* Current or past substance use disorder (including alcohol or cannabinoids)
* Excessive caffeine consumption (\> 600 mg/day)
* Prior treatment with either FT218 or LUMRYZ

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No