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Trial · NCT04451668

An Open Label Study of FT218 in Subjects With Narcolepsy

NCT04451668, Phase 3, Completed, Avadel

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. An Open Label Study of FT218 in Subjects With Narcolepsy. Trials, record NCT04451668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04451668

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
An Open Label Study of FT218 in Subjects With Narcolepsy
NCT number
NCT04451668
Status
Completed
Phases
Phase 3
Enrollment
184 participants, actual
Lead sponsor
Avadel
Conditions
Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders
Interventions
FT218
First posted
2020-06-30
Last updated
2025-10-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-related adverse events24 monthsAssess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
PrimaryIncidence of clinically significant changes in vital signs24 monthsAssess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
PrimaryIncidence of clinically significant changes in laboratory test results24 monthsAssess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results

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.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
39263597DERIVEDPubMed
42163487DERIVEDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04451668

GET https://conductscience.org/api/trials/v1/NCT04451668/registered