Clinical trial NCT06525077: Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Idiopathic Hypersomnia
Lead sponsor: Avadel
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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)
* Excessive caffeine consumption (\> 600 mg/day)
* Prior treatment with either FT218 or LUMRYZ

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Secondary outcomes:
measure: Patient Global Impression of change (PGI-C)
timeFrame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
measure: Idiopathic Hypersomnia Severity Scale (IHSS)
timeFrame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
measure: Clinical Global Impression of change (CGI-C)
timeFrame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
measure: Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Winter Park
country: United States
facility: Florida Pediatric Institute
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services PC
state: Michigan
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: Williamsburg
country: United States
facility: Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
state: Virginia
Study officials:
References: