Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06525077 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
A Phase 3 study of Idiopathic Hypersomnia, sponsored by Avadel.
- Active
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 7
- Study locations
NCT06525077: Active Phase 3 study of Idiopathic Hypersomnia, sponsored by Avadel.
NCT06525077 is a Phase 3 study of Idiopathic Hypersomnia that is active but no longer recruiting, run by Avadel. The registered enrollment target is 150 participants, above the 100-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (50% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06525077, a Phase 3 study of Idiopathic Hypersomnia, is active but no longer recruiting, sponsored by Avadel.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Change in total ESS score
Conditions Studied
Interventions
- OTHER Placebo
- DRUG FT218
Study Locations (7)
Colorado
- Alpine Clinical Research Center - Boulder
Florida
- Florida Pediatric Institute - Winter Park
Georgia
- Clinical Research Institute - Stockbridge
Michigan
- Clinical Neurophysiology Services PC - Sterling Heights
North Carolina
- Advanced Respiratory and Sleep Medicine - Huntersville
South Carolina
- Bogan Sleep Consultants - Columbia
Virginia
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research - Williamsburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT06525077 still lists
NCT06525077 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06525077 lists 7 locations in 7 states (Colorado, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT06525077 about?
NCT06525077 is a clinical study titled "Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)". 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 hypersom...
What is the current status of trial NCT06525077?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-08-01. Estimated completion is 2026-03.
What conditions does trial NCT06525077 study?
This clinical trial studies the following conditions: Idiopathic Hypersomnia.
What interventions are being tested in trial NCT06525077?
The interventions under investigation include: Placebo (OTHER), FT218 (DRUG).
Who is sponsoring clinical trial NCT06525077?
This trial is sponsored by Avadel, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06525077 being conducted?
This trial has 7 study locations across Colorado, Florida, Georgia, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Hypersomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
RECRUITING · Phase 2
-
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
RECRUITING · Phase 2
-
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
RECRUITING · Phase 2
-
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
RECRUITING · Phase 2
-
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
RECRUITING · Phase 4
-
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI