Trial · NCT01430754

Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder

NCT01430754, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2014-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder. Trials, record NCT01430754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430754

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Trial

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

Title: Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
NCT number: NCT01430754
Status: Completed
Phases: Phase 3
Enrollment: 20 participants, actual
Lead sponsor: Vanda Pharmaceuticals
Conditions: Non-24-Hour Sleep-Wake Disorder
Interventions: tasimelteon, Placebo
First posted: 2011-09-08
Last updated: 2014-10-10
Results first posted: 2014-10-10

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.	Approximately 12 weeks	Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI \>24.0.
Secondary	Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD	Approximately 12 weeks	Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI \>24.0.
Secondary	Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase	Approximately 12 weeks	LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.
Secondary	Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase	Approximately 12 weeks	UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.
Secondary	Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase	Approximately 12 weeks	Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.
Secondary	Change From Run-In in Circadian Time to Relapse During the Randomized Phase	Approximately 8 weeks	Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.	Approximately 12 weeks	participants	NUMBER
SECONDARY	Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD	Approximately 12 weeks	participants	NUMBER
SECONDARY	Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase	Approximately 12 weeks	minutes	MEAN
SECONDARY	Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase	Approximately 12 weeks	minutes	MEAN
SECONDARY	Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase	Approximately 12 weeks	minutes	MEAN
SECONDARY	Change From Run-In in Circadian Time to Relapse During the Randomized Phase	Approximately 8 weeks	days	MEDIAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.	Tasimelteon	9		participants
Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.	Placebo	2		participants
Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD	Tasimelteon	8		participants
Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD	Placebo	2		participants
Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase	Tasimelteon	-6.74	Standard Error 18.986	minutes
Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase	Placebo	-73.74	Standard Error 18.986	minutes
Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase	Tasimelteon	-9.31	Standard Error 17.253	minutes
Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase	Placebo	49.95	Standard Error 17.253	minutes
Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase	Tasimelteon	19.99	Standard Error 8.611	minutes
Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase	Placebo	-16.05	Standard Error 8.611	minutes

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow14

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

Period	Milestone	Group	Participants
Run-In Phase	STARTED	Tasimelteon	57
Run-In Phase	STARTED	Placebo	0
Run-In Phase	Entrained - After Run-In Phase	Tasimelteon	24
Run-In Phase	Entrained - After Run-In Phase	Placebo	0
Run-In Phase	COMPLETED	Tasimelteon	20
Run-In Phase	COMPLETED	Placebo	0
Run-In Phase	NOT COMPLETED	Tasimelteon	37
Run-In Phase	NOT COMPLETED	Placebo	0
Randomized Phase	STARTED	Tasimelteon	10
Randomized Phase	STARTED	Placebo	10

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events64

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	Nasopharyngitis	Infections and infestations	Total Run-In	4	57	4
other	Nasopharyngitis	Infections and infestations	Run-In - Not Randomized	2	37	2
other	Nasopharyngitis	Infections and infestations	Tasimelteon	0	10	0
other	Nasopharyngitis	Infections and infestations	Placebo	0	10	0
other	Blood creatine phosphokinase	Investigations	Total Run-In	3	57	3
other	Blood creatine phosphokinase	Investigations	Run-In - Not Randomized	0	37	0
other	Blood creatine phosphokinase	Investigations	Tasimelteon	0	10	0
other	Blood creatine phosphokinase	Investigations	Placebo	0	10	0
other	Alanine aminotransferase	Investigations	Total Run-In	2	57	2
other	Alanine aminotransferase	Investigations	Run-In - Not Randomized	0	37	0

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Total Run-In
Total, all-cause mortality	Run-In - Not Randomized
Total, all-cause mortality	Tasimelteon
Total, all-cause mortality	Placebo
Total, other adverse events	Total Run-In	16	57
Total, other adverse events	Run-In - Not Randomized	10	37
Total, other adverse events	Tasimelteon	5	10
Total, other adverse events	Placebo	0	10
Total, serious adverse events	Total Run-In	1	57
Total, serious adverse events	Run-In - Not Randomized	0	37

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26466871	DERIVED

Source 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
Tasimelteon vs Placebo: Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.	Trial comparisons
Tasimelteon vs Placebo: Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD	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/NCT01430754

GET https://conductscience.org/api/trials/v1/NCT01430754/events?page=2

API reference For AI assistants