Trial · NCT06525077
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
NCT06525077, Phase 3, Completed, Avadel
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ). Trials, record NCT06525077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06525077
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
- NCT number
- NCT06525077
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 157 participants, actual
- Lead sponsor
- Avadel
- Conditions
- Idiopathic Hypersomnia
- Interventions
- FT218, Placebo
- First posted
- 2024-07-29
- Last updated
- 2026-05-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06525077
GET https://conductscience.org/api/trials/v1/NCT06525077/registered