Trial · NCT00620659

Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)

NCT00620659, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2011-02-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015). Trials, record NCT00620659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620659

On this page

Trial

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

Title: Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
NCT number: NCT00620659
Status: Terminated
Phases: Phase 2
Enrollment: 125 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Sleep Apnea, Obstructive, Hypopnea Syndrome, Excessive Daytime Sleepiness
Interventions: Comparator: MK0249, Comparator: placebo, Comparator: modafinil
First posted: 2008-02-21
Last updated: 2015-05-13
Results first posted: 2011-02-23

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo	At Week 2	The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
Secondary	Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil	At Week 2	The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.
Secondary	Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil	At Week 2	The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.
Secondary	Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo	At Week 2	Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.
Secondary	Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo	At Week 2	The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 ("would never dose") to 3 ("high chance of dozing"). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse).

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo	At Week 2	Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil	At Week 2	Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil	At Week 2	Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo	At Week 2	Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo	At Week 2	Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo	Placebo	12.79	Standard Error 0.75	Minutes
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo	MK0249 Mode Dose	13.34	Standard Error 1.09	Minutes
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil	MK0249 Mode Dose	13.34	Standard Error 1.09	Minutes
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil	Modafinil 200 mg	17.45	Standard Error 0.74	Minutes
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil	MK0249 Top 2 Doses Pooled	13.64	Standard Error 0.85	Minutes
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil	Modafinil 200 mg	17.45	Standard Error 0.74	Minutes
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo	Placebo	3.76	Standard Error 0.11	units on a scale
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo	MK0249 Mode Dose	3.43	Standard Error 0.18	units on a scale
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo	Placebo	12.81	Standard Error 0.43	units on a scale
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo	MK0249 Mode Dose	10.83	Standard Error 0.65	units on a scale

Source ClinicalTrials.gov

Participant flow90

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

Period	Milestone	Group	Participants
Treatment Period 1	STARTED	MK0249/Placebo/Modafinil	21
Treatment Period 1	STARTED	Placebo/Modafinil/MK0249	21
Treatment Period 1	STARTED	Modafinil/MK0249/Placebo	21
Treatment Period 1	STARTED	MK0249/Modafinil/Placebo	21
Treatment Period 1	STARTED	Placebo/MK0249/Modafinil	21
Treatment Period 1	STARTED	Modafinil/Placebo/MK0249	20
Treatment Period 1	COMPLETED	MK0249/Placebo/Modafinil	18
Treatment Period 1	COMPLETED	Placebo/Modafinil/MK0249	21
Treatment Period 1	COMPLETED	Modafinil/MK0249/Placebo	20
Treatment Period 1	COMPLETED	MK0249/Modafinil/Placebo	18

1 to 10 of 90Source ClinicalTrials.gov

See all 90 participant flow

Adverse events852

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
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	117
other	Anaemia	Blood and lymphatic system disorders	MK0249 5 mg	0	10
other	Anaemia	Blood and lymphatic system disorders	MK0249 8 mg	0	25
other	Anaemia	Blood and lymphatic system disorders	MK0249 10 mg	0	46
other	Anaemia	Blood and lymphatic system disorders	MK0249 12 mg	0	39
other	Anaemia	Blood and lymphatic system disorders	Modafinil	0	111
other	Atrioventricular block first degree	Cardiac disorders	Placebo	0	117
other	Atrioventricular block first degree	Cardiac disorders	MK0249 5 mg	0	10
other	Atrioventricular block first degree	Cardiac disorders	MK0249 8 mg	1	25
other	Atrioventricular block first degree	Cardiac disorders	MK0249 10 mg	0	46

1 to 10 of 852Source ClinicalTrials.gov

See all 852 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	MK0249 5 mg
Total, all-cause mortality	MK0249 8 mg
Total, all-cause mortality	MK0249 10 mg
Total, all-cause mortality	MK0249 12 mg
Total, all-cause mortality	Modafinil
Total, other adverse events	Placebo	41	117
Total, other adverse events	MK0249 5 mg	6	10
Total, other adverse events	MK0249 8 mg	7	25
Total, other adverse events	MK0249 10 mg	16	46

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23920422	RESULT

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 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.

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