Treatment of Refractory Excessive Daytime Sleepiness in P... | NCT00620659 | Trialant
NCT00620659
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
May 13, 2015Estimated
Enrollment
125Actual
Phase
Phase 2
Conditions
Sleep Apnea, Obstructive
Hypopnea Syndrome
Excessive Daytime Sleepiness
Interventions
Comparator: MK0249
Comparator: placebo
Comparator: modafinil
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00620659
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0249-015
Secondary IDs
ID
Type
Description
Link
2007_602
Brief 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)
Official Title
Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Apr 2015
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2008
Primary Completion Date
Feb 2009Actual
Completion Date
Feb 2009Actual
First Submitted Date
Jan 10, 2008
First Submission Date that Met QC Criteria
Feb 11, 2008
First Posted Date
Feb 21, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 13, 2010
Results First Submitted that Met QC Criteria
Jan 27, 2011
Results First Posted Date
Feb 23, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 27, 2015
Last Update Posted Date
May 13, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Sleep Apnea, Obstructive
Hypopnea Syndrome
Excessive Daytime Sleepiness
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
125Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
2
Experimental
Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
3
Experimental
Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
4
Experimental
Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
5
Experimental
Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Comparator: MK0249
Drug
Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
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.
At Week 2
Secondary Outcomes
Measure
Description
Time Frame
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient is male or female and is at least 18 years old and less than 65 years old
Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
Patient is willing to refrain from napping for the duration of the study
Exclusion Criteria:
Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants maintained sleep and sleepiness diaries during a 7- to 10-day placebo run-in period. They used a nasal continuous positive airway pressure (nCPAP) device to monitor their CPAP use. At the end of the run-in period, participants stayed overnight at the clinic for nighttime polysomnography and if eligible, were randomized the next morning
Recruitment Details
The majority of patients were recruited from investigators' own databases at 24 sites in the United States. The primary therapy period was 13-Mar-2008 to 25-Feb-2009.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK0249/Placebo/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
6
Experimental
Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249
Drug: Comparator: MK0249
Drug: Comparator: placebo
Drug: Comparator: modafinil
1
2
3
4
5
6
Comparator: placebo
Drug
Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
1
2
3
4
5
6
Comparator: modafinil
Drug
Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
1
2
3
4
5
6
At Week 2
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
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.
At Week 2
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
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.
At Week 2
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
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).
At Week 2
FG001
Placebo/Modafinil/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
FG002
Modafinil/MK0249/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
FG003
MK0249/Modafinil/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
FG004
Placebo/MK0249/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
FG005
Modafinil/Placebo/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
FG00021 subjects
FG00121 subjects
FG00221 subjects
FG00321 subjects
FG00421 subjects
FG00520 subjects
COMPLETED
FG00018 subjects
FG00121 subjects
FG00220 subjects
FG00318 subjects1 patient discontinued from MK0249, but continued in following periods, \& completed the study
FG00420 subjects
FG00520 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG0041 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Placebo Washout Period 1
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00121 subjects
FG00220 subjects
FG00319 subjects
FG00420 subjects
FG00520 subjects
COMPLETED
FG00018 subjects
FG00121 subjects
FG00220 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Treatment Period 2
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00121 subjects
FG00220 subjects
FG00318 subjects
FG00420 subjects
FG00520 subjects
COMPLETED
FG00018 subjects
FG00118 subjects
FG00219 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG003
Placebo Washout Period 2
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00118 subjects
FG00219 subjects
FG00318 subjects
FG00415 subjects
FG00520 subjects
COMPLETED
FG00016 subjects
FG00118 subjects
FG00219 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Treatment Period 3
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00118 subjects
FG00219 subjects
FG00318 subjects
FG00415 subjects
FG00520 subjects
COMPLETED
FG00016 subjects
FG00116 subjects
FG00219 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Randomized Participants
All participants randomized in study
Denominators
Units
Counts
Participants
BG000125
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.6± 8.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
Male
BG000100
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG000102
Black or African American
Title
Measurements
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
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.
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.
Posted
Least Squares Mean
Standard Error
Minutes
At Week 2
ID
Title
Description
OG000
Placebo
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
OG001
MK0249 Mode Dose
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
Units
Counts
Participants
OG000116
OG00139
Title
Denominators
Categories
Title
Measurements
OG00012.79± 0.75
OG00113.34± 1.09
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
The mixed model included terms for period and treatment.
0.615
95
No
Superiority or Other
Secondary
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
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.
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.
Posted
Least Squares Mean
Standard Error
Minutes
At Week 2
ID
Title
Description
OG000
MK0249 Mode Dose
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
OG001
Modafinil 200 mg
There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
Secondary
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
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.
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.
Posted
Least Squares Mean
Standard Error
Minutes
At Week 2
ID
Title
Description
OG000
MK0249 Top 2 Doses Pooled
The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.
There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively).
OG001
Modafinil 200 mg
There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
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
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
At Week 2
ID
Title
Description
OG000
Placebo
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
OG001
MK0249 Mode Dose
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
Secondary
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
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).
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.
Posted
Least Squares Mean
Standard Error
units on a scale
At Week 2
ID
Title
Description
OG000
Placebo
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
OG001
MK0249 Mode Dose
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
Time Frame
Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Description
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
2
117
41
117
EG001
MK0249 5 mg
MK0249 was provided as 1 mg and 5 mg tablets.
0
10
6
10
EG002
MK0249 8 mg
MK0249 was provided as 1 mg and 5 mg tablets.
0
25
7
25
EG003
MK0249 10 mg
MK0249 was provided as 1 mg and 5 mg tablets.
0
46
16
46
EG004
MK0249 12 mg
MK0249 was provided as 1 mg and 5 mg tablets.
0
39
25
39
EG005
Modafinil
Modafinil was provided as 100 mg tablets.
0
111
38
111
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute pericarditis
Cardiac disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG0030 affected46 at risk
EG0040 affected39 at risk
EG0050 affected111 at risk
Lymph node abscess
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Essential thrombocythaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG0030 affected46 at risk
EG0040 affected39 at risk
EG0050 affected111 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Ear buzzing
Ear and labyrinth disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Scleral haemorrhage
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Subconjunctival ecchymosis
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Bloating
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Burping
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Gastric pain
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Malodorous burping
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Stomach ache
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Stomach fullness
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Upset stomach
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Application site rash
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chest pain
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chest pressure
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Chest tightness
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chills
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Fatigue
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Fever
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Foot oedema
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hand swelling
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hangover
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Implant site pain
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Increased thirst
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Irritability
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Malaise
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Liver fatty
Hepatobiliary disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Cold
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Cold sores
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Cold symptoms
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Head cold
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Infection
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Pinkeye
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sinus infection
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Yeast infection
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Back strain
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Contusion of upper arm
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Device induced injury
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Laceration of foot
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lateral epicondylitis
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Leg injury
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Pulled muscle
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Shoulder sprain
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Blood pressure increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Blood sugar increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Creatine phosphokinase increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0011 affected10 at risk
EG0021 affected25 at risk
EG003
Glucose increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Glucose urine increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Heart rate increased
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Urine calcium oxalate crystal present
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Appetite lost
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Back ache
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chest wall pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Knee pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Leg cramps
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Low back pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Muscle ache
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Pain in leg
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sore back
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Upper back pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Attention concentration difficulty
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Concentration impaired
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Head pressure
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0007 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Headache dull
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Hypnagogic myoclonus
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Lightheadedness
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nocturnal headache
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sinus pressure
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Taste metallic
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Tingling feet/hands
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Tremor
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0023 affected25 at risk
EG003
Bad dreams
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Confusion
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dreaming excessive
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0023 affected25 at risk
EG003
Middle insomnia
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Mood change
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nocturnal awakening
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sleep maintenance insomnia
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sleep talking
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Stress
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Teeth clenching
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Vivid dreams
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Kidney stone
Renal and urinary disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Urinary frequency
Renal and urinary disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Ejaculation delayed
Reproductive system and breast disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Breath shortness
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Dry cough
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nasal sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nasal sinus discharge
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nasal stuffiness
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sore throat
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Clamminess
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Diaphoresis
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hives
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Ingrown toe nail
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Localised erythema
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Feeling of hot flushes
Vascular disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Generalised flushing
Vascular disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Haematoma
Vascular disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected117 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hot flush
Vascular disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected117 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D020181
Sleep Apnea, Obstructive
D006970
Disorders of Excessive Somnolence
Ancestor Terms
ID
Term
D012891
Sleep Apnea Syndromes
D001049
Apnea
D012120
Respiration Disorders
D012140
Respiratory Tract Diseases
D020919
Sleep Disorders, Intrinsic
D020920
Dyssomnias
D012893
Sleep Wake Disorders
D009422
Nervous System Diseases
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
20 subjects
FG00520 subjects
0 subjects
FG0050 subjects
1 subjects
FG0040 subjects
FG0050 subjects
15 subjects
FG00520 subjects
5 subjects
FG0050 subjects
0 subjects
FG0042 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
15 subjects
FG00520 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
15 subjects
FG00520 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
19
American Indian or Alaska Native
Title
Measurements
BG0001
Asian
Title
Measurements
BG0003
Units
Counts
Participants
OG00039
OG001106
Title
Denominators
Categories
Title
Measurements
OG00013.34± 1.09
OG00117.45± 0.74
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Least Squares Mean
-4.11
2-Sided
90
-5.92
-2.30
Yes
Non-Inferiority or Equivalence
The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.
Units
Counts
Participants
OG00074
OG001106
Title
Denominators
Categories
Title
Measurements
OG00013.64± 0.85
OG00117.45± 0.74
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Least Squares Mean
-3.80
2-Sided
90
-5.23
-2.38
Yes
Non-Inferiority or Equivalence
The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.
Units
Counts
Participants
OG000116
OG00139
Title
Denominators
Categories
Title
Measurements
OG0003.76± 0.11
OG0013.43± 0.18
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
The mixed model included terms for period and treatment.
0.079
95
No
Superiority or Other
Units
Counts
Participants
OG000115
OG00140
Title
Denominators
Categories
Title
Measurements
OG00012.81± 0.43
OG00110.83± 0.65
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
The mixed model included terms for period and treatment.