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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7288-010 | Other Identifier | Merck study number |
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This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil | Experimental | Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
|
| MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo | Experimental | Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
|
| Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg | Experimental | Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
|
| Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg | Experimental | Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7288 | Drug | one or two 10 mg capsules, orally, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. | 1, 3, 5 and 7 hours post dose |
| Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo | Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. | 2, 4 and 6 hours post dose |
| Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE. | Up to 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24122944 | Result | Sun H, MacLeod C, Mostoller K, Mahon C, Han L, Renger JJ, Ma J, Brown KR, Schulz V, Kay GG, Herring WJ, Lines C, Rosen LB, Murphy MG, Wagner JA. Early-stage comparative effectiveness: randomized controlled trial with histamine inverse agonist MK-7288 in excessive daytime sleepiness patients. J Clin Pharmacol. 2013 Dec;53(12):1294-302. doi: 10.1002/jcph.182. Epub 2013 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil | Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| FG001 | MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo | Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| FG002 | Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg | Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| FG003 | Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg | Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout Period 1 |
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| Treatment Period 2 |
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| Washout Period 2 |
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| Treatment Period 3 |
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| Washout Period 3 |
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| Treatment Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All participants who were randomized in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. | The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | Minutes | 1, 3, 5 and 7 hours post dose |
|
Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-7288 10 mg | Participants received single doses of MK-7288 10 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eructation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| C000589274 | MK-7288 |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo to MK-7288 | Drug | one or two capsules, orally, single dose |
|
| Modafinil | Drug | two 100 mg tablets, orally, single dose |
|
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| Placebo to modafinil | Drug | two 100 mg tablets, orally, single dose |
|
| 1, 3, 5 and 7 hours post dose |
| Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. | 1, 3, 5 and 7 hours post dose |
| Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo | Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. | 2, 4 and 6 hours post dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received single doses of MK-7288 10 mg.
| OG001 | MK-7288 20 mg | Participants received single doses of MK-7288 20 mg. |
| OG002 | Modafinil 200 mg | Participants received single doses of Modafinil 200 mg. |
| OG003 | Placebo | Participants received single doses of Placebo. |
|
|
|
| Primary | Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo | Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. | The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | Meters | 2, 4 and 6 hours post dose |
|
|
|
|
| Primary | Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE. | All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to 36 days |
|
|
|
| Secondary | Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. | The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | Minutes | 1, 3, 5 and 7 hours post dose |
|
|
|
|
| Secondary | Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo | Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. | The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | Minutes | 1, 3, 5 and 7 hours post dose |
|
|
|
|
| Secondary | Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo | Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. | The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period. | Posted | Least Squares Mean | 90% Confidence Interval | Meters | 2, 4 and 6 hours post dose |
|
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|
|
| 1 |
| 54 |
| 24 |
| 54 |
| EG001 | MK-7288 20 mg | Participants received single doses of MK-7288 20 mg. | 1 | 55 | 29 | 55 |
| EG002 | Modafinil 200 mg | Participants received single doses of Modafinil 200 mg. | 0 | 53 | 12 | 53 |
| EG003 | Placebo | Participants received single doses of Placebo. | 0 | 52 | 5 | 52 |
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Difference in LS means |
| -0.07 |
| 2-Sided |
| 95 |
| -0.09 |
| -0.05 |
| Superiority or Other |
| Laboratory AE |
|
| Difference in LS means |
| -2.10 |
| 2-Sided |
| 90 |
| -3.79 |
| -0.40 |
| Superiority or Other |