Idiopathic Hypersomnia
Conditions
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.
Interventions
DRUGFT218
Sodium oxybate for extended-release oral suspension
OTHERPlacebo
Matched placebo equivalent for oral suspension
Sponsors
Avadel
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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] | Worsening of idiopathic hypersomnia symptoms as assessed by subject |
| 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] | Change in total IHSS score |
| 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] | Worsening of idiopathic hypersomnia symptoms as assessed by clinician |
| 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] | Change in total FOSQ-10 score |
Countries
United States
Outcome results
None listed