A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)

Avadel7 sites in 1 country150 target enrollmentAugust 1, 2024

ConditionsIdiopathic Hypersomnia

InterventionsFT218 Placebo

DrugsFT218

Overview

Phase: Phase 3
Intervention: FT218
Conditions: Idiopathic Hypersomnia
Sponsor: Avadel
Enrollment: 150
Locations: 7
Primary Endpoint: Epworth Sleepiness Scale (ESS)
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2024

End Date

March 1, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Avadel

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

FT218

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

Intervention: FT218

Placebo

Placebo equivalent administered orally once nightly

Intervention: Placebo

Outcomes

Primary Outcomes

Epworth Sleepiness Scale (ESS)

Time Frame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]

Change in total ESS score

Secondary Outcomes

Patient Global Impression of change (PGI-C)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
Idiopathic Hypersomnia Severity Scale (IHSS)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
Clinical Global Impression of change (CGI-C)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
Functional Outcomes of Sleep Questionnaire (FOSQ-10)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])