Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Public ClinicalTrials.gov record NCT06525077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 identification
- NCT ID
- NCT06525077
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Avadel
- Industry
- Enrollment
- 157 participants
Conditions and interventions
Conditions
Interventions
- FT218 Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2024
- Primary completion
- Mar 24, 2026
- Completion
- Mar 24, 2026
- Last update posted
- May 10, 2026
2024 – 2026
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Florida Pediatric Institute | Winter Park | Florida | 32789 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Clinical Neurophysiology Services PC | Sterling Heights | Michigan | 48314 | — |
| Advanced Respiratory and Sleep Medicine | Huntersville | North Carolina | 28078 | — |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | — |
| Tidewater Physicians Multispecialty Group (TPMG) Clinical Research | Williamsburg | Virginia | 23188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06525077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06525077 live on ClinicalTrials.gov.