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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 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.

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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.

Conditions Studied

Idiopathic Hypersomnia

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

FieldValue
Enrollment Target 150 participants
Start Date 2024-08-01
Est. Completion 2026-03
Phase Phase 3

Sponsor

Avadel

4 total trials

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What the Registry Record Tells You About NCT06525077

The ClinicalTrials.gov registry entry for NCT06525077 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (50% higher). The listed sponsor is Avadel, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.