Trial · NCT02720744

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

NCT02720744, Phase 3, Completed, Avadel; results first posted 2022-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy. Trials, record NCT02720744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720744

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Trial

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

Title: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
NCT number: NCT02720744
Status: Completed
Phases: Phase 3
Enrollment: 212 participants, actual
Lead sponsor: Avadel
Conditions: Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
Interventions: FT218, Placebo
First posted: 2016-03-28
Last updated: 2022-03-22
Results first posted: 2022-03-22

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Maintenance of Wakefulness Test (MWT)	Study Visit 8 at 14 weeks	Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Primary	Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening	Study Visit 8 at 14 weeks	The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Primary	Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline	Visit 8 - Change from Baseline at 14 Weeks	Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maintenance of Wakefulness Test (MWT)	Study Visit 8 at 14 weeks	Maintenance of Wakefulness Test (MWT) Mean Sleep Latency (Minutes) Change from Baseline to the End of the 9.0g Treatment Period - MMRM (mixed model repeat measure) Analysis (mITT Population)	minutes	MEAN
PRIMARY	Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening	Study Visit 8 at 14 weeks	Clinical Global Impression - Improvement (CGI-I) by the End of 9.0g Treatment Period	percentage of subjects	NUMBER
PRIMARY	Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline	Visit 8 - Change from Baseline at 14 Weeks	Mean Weekly Number of Cataplexy Attacks (NCA) of Each Dosing Period, Change from Baseline to the End of 9.0g Treatment Period - MMRM Analysis (NT1 Subjects in mITT Population)	Cataplexy Attacks	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maintenance of Wakefulness Test (MWT)	FT218	10.8	Standard Deviation 0.96	minutes
Maintenance of Wakefulness Test (MWT)	Placebo	4.7	Standard Deviation 0.92	minutes
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening	FT218	72.0		percentage of subjects
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening	Placebo	31.6		percentage of subjects
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline	FT218	-11.5	Standard Deviation 0.96	Cataplexy Attacks
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline	Placebo	-4.9	Standard Deviation 0.95	Cataplexy Attacks

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FT218	107
Overall Study	STARTED	Placebo	105
Overall Study	COMPLETED	FT218	69
Overall Study	COMPLETED	Placebo	79
Overall Study	NOT COMPLETED	FT218	38
Overall Study	NOT COMPLETED	Placebo	26

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	FT218 9g Group	4	77	4
other	Dizziness	Nervous system disorders	Placebo 9g Group	0	80	0
other	Somnolence	Nervous system disorders	FT218 9g Group	3	77	3
other	Somnolence	Nervous system disorders	Placebo 9g Group	0	80	0
other	Enuresis	Psychiatric disorders	FT218 9g Group	7	77	9
other	Enuresis	Psychiatric disorders	Placebo 9g Group	0	80	0
other	Vomiting	Gastrointestinal disorders	FT218 9g Group	4	77	5
other	Vomiting	Gastrointestinal disorders	Placebo 9g Group	0	80	0
other	Decreased Appetite	Metabolism and nutrition disorders	FT218 9g Group	2	77	2
other	Decreased Appetite	Metabolism and nutrition disorders	Placebo 9g Group	0	80	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FT218 9g Group	0	77
Total, all-cause mortality	Placebo 9g Group	0	80
Total, other adverse events	FT218 9g Group	23	77
Total, other adverse events	Placebo 9g Group	6	80
Total, serious adverse events	FT218 9g Group	1	77
Total, serious adverse events	Placebo 9g Group	0	80

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34358324	DERIVED	PubMed
35380374	DERIVED	PubMed
39153911	DERIVED	PubMed
39321628	DERIVED	PubMed
40111738	DERIVED	PubMed
40111739	DERIVED	PubMed
40851446	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
FT218 9g Group vs Placebo 9g Group: deaths from any cause	Trial comparisons
FT218 9g Group vs Placebo 9g Group: serious adverse events	Trial comparisons

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/NCT02720744

GET https://conductscience.org/api/trials/v1/NCT02720744/registered

API reference For AI assistants