Trials / Active Not Recruiting
Active Not RecruitingNCT06525077
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Avadel · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT218 | Sodium oxybate for extended-release oral suspension |
| OTHER | Placebo | Matched placebo equivalent for oral suspension |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2024-07-29
- Last updated
- 2026-02-13
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06525077. Inclusion in this directory is not an endorsement.