Apnea, SleepPhase 1NCT01092780

Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)

A Phase 1 study testing MK-7288 and Modafinil in people with Apnea, Sleep, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Apnea, Sleep
What is being tested?: MK-7288 and Modafinil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: No sites listed yet
Study dates: 26 May 2010to 31 May 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Female participants are of non-child-bearing potential.
Male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study.
Participant has an International Classification of Sleep Disorders diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome.
Participant has excessive daytime sleepiness.
Participant has been using nCPAP treatment for at least 2 months.
Participant reported total sleep time of >6 hours on at least 4 out of 7 nights each week

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Participant is willing to stay at the sleep laboratory for 5 overnight stays.
Participant is willing to limit caffeine and alcohol consumption during the study.
Participant has a valid driver's license in the past 5 years and has had at least 1 year of driving experience within the past 3 years.
Participant's regular bedtime is between 9:00 p.m. and 12:00 a.m.

Who cannot join

Participant has a history of cancer.
Participant has any history of a significant neurological disorder.
Participant has moderate or severe persistent asthma.
Participant has a history of any of the following sleep disorders: narcolepsy, primary insomnia, Circadian rhythm sleep disorder, shift work sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, rapid eye movement (REM) behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or restless leg syndrome.
Participant consumes more than 10 cigarettes a day or routinely smokes during the night.
Participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab abnormality or circumstances that might confound the results of the study, or interfere with participation for the full duration of the study.

About this study

Official title: An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients

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).

Conditions: Apnea, Sleep
Being tested: MK-7288, Placebo to MK-7288, Modafinil, Placebo to modafinil
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-7288Drug
one or two 10 mg capsules, orally, single dose
Placebo to MK-7288Drug
one or two capsules, orally, single dose
ModafinilDrug
Also called PROVIGIL®
two 100 mg tablets, orally, single dose
Placebo to modafinilDrug
two 100 mg tablets, orally, single dose

Study groups in NCT01092780
Study group	Role	What they receive
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. Receives: Drug: MK-7288; Drug: Placebo to MK-7288; Drug: Modafinil; Drug: Placebo to modafinil
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. Receives: Drug: MK-7288; Drug: Placebo to MK-7288; Drug: Modafinil; Drug: Placebo to modafinil
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. Receives: Drug: MK-7288; Drug: Placebo to MK-7288; Drug: Modafinil; Drug: Placebo to modafinil
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. Receives: Drug: MK-7288; Drug: Placebo to MK-7288; Drug: Modafinil; Drug: Placebo to modafinil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Up to 36 days

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 2, 4 and 6 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 201031 May 2011

First posted25 Mar 2010 (estimated)
Study start26 May 2010
Primary completion31 May 2011
Study completion31 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Apnea, SleepStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01092780
Sponsor's protocol ID: 7288-010
Other IDs: MK-7288-010
Status last verified: Oct 2018
First submitted: 23 Mar 2010
Last updated: 8 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 24122944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Apnea, Sleep trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients
ClinicalTrials.gov ID: NCT01092780
Acronym / sponsor ID: 7288-010
Conditions: Apnea, Sleep
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 26 May 2010 (actual)
Primary completion: 31 May 2011 (actual)
Study completion: 31 May 2011 (actual)
First posted: 25 Mar 2010 (estimated)
Results: Posted 22 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil	Experimental	Drug: MK-7288, Drug: Placebo to MK-7288, Drug: Modafinil, Drug: Placebo to modafinilParticipants 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	Drug: MK-7288, Drug: Placebo to MK-7288, Drug: Modafinil, Drug: Placebo to modafinilParticipants 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	Drug: MK-7288, Drug: Placebo to MK-7288, Drug: Modafinil, Drug: Placebo to modafinilParticipants 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	Drug: MK-7288, Drug: Placebo to MK-7288, Drug: Modafinil, Drug: Placebo to modafinilParticipants 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Female participants are of non-child-bearing potential.
Male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study.
Participant has an International Classification of Sleep Disorders diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome.
Participant has excessive daytime sleepiness.
Participant has been using nCPAP treatment for at least 2 months.

Key exclusion criteria (6 listed)

Participant has a history of cancer.
Participant has any history of a significant neurological disorder.
Participant has moderate or severe persistent asthma.
Participant has a history of any of the following sleep disorders: narcolepsy, primary insomnia, Circadian rhythm sleep disorder, shift work sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, rapid eye movement (REM) behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or restless leg syndrome.
Participant consumes more than 10 cigarettes a day or routinely smokes during the night.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-7288one or two 10 mg capsules, orally, single dose	Drug	MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil, MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo, Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg, Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg
Placebo to MK-7288one or two capsules, orally, single dose	Drug	MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil, MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo, Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg, Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg
ModafinilAlso: PROVIGIL®two 100 mg tablets, orally, single dose	Drug	MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil, MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo, Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg, Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg
Placebo to modafiniltwo 100 mg tablets, orally, single dose	Drug	MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil, MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo, Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg, Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg

Primary outcome

Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo
Time frame: 1, 3, 5 and 7 hours post dose
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.
Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo
Time frame: 2, 4 and 6 hours post dose
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.
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Time frame: Up to 36 days
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.

3 secondary outcomes

Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil
Time frame: 1, 3, 5 and 7 hours post dose
Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo
Time frame: 1, 3, 5 and 7 hours post dose
Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo
Time frame: 2, 4 and 6 hours post dose

Results and safety

Results posted to the registry on 22 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil	14	14
MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo	15	15
Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg	14	14
Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg	13	13

Primary outcome: Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo

Time frame: 1, 3, 5 and 7 hours post dose. Least squares mean (95% Confidence Interval). Unit: Minutes

Measure	MK-7288 10 mg n = 54	MK-7288 20 mg n = 55	Modafinil 200 mg n = 53	Placebo n = 52
Value	18.66 (16.54 to 20.79)	18.62 (16.50 to 20.73)	20.71 (18.57 to 22.85)	10.50 (8.35 to 12.65)

MK-7288 10 mg vs Placebo: Difference in LS means: 8.16 (95% CI 6.11 to 10.20)
MK-7288 20 mg vs Placebo: Difference in LS means: 8.11 (95% CI 6.07 to 10.15)

Population analysed: 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.

Primary outcome: Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo

Time frame: 2, 4 and 6 hours post dose. Least squares mean (95% Confidence Interval). Unit: Meters

Measure	MK-7288 10 mg n = 54	MK-7288 20 mg n = 55	Modafinil 200 mg n = 53	Placebo n = 52
Value	0.31 (0.28 to 0.35)	0.32 (0.28 to 0.35)	0.32 (0.29 to 0.36)	0.39 (0.36 to 0.42)

MK-7288 10 mg vs Placebo: Difference in LS means: -0.07 (95% CI -0.10 to -0.05)
MK-7288 20 mg vs Placebo: Difference in LS means: -0.07 (95% CI -0.09 to -0.05)

Population analysed: The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.

Primary outcome: Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)

Time frame: Up to 36 days. Number. Unit: Participants

Measure	MK-7288 10 mg n = 54	MK-7288 20 mg n = 55	Modafinil 200 mg n = 53	Placebo n = 52
Clinical AE	30	37	16	12
Laboratory AE	1	1	0	1

Population analysed: All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 days (Up to 3-4 days after last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-7288 10 mg	1 of 54 (1.9%)	24 of 54 (44.4%)	Not reported
MK-7288 20 mg	1 of 55 (1.8%)	29 of 55 (52.7%)	Not reported
Modafinil 200 mg	0 of 53 (0%)	12 of 53 (22.6%)	Not reported
Placebo	0 of 52 (0%)	5 of 52 (9.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24122944Sun 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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Apnea, Sleep

RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-7288 and Modafinil in people with Apnea, Sleep, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo (time frame: 1, 3, 5 and 7 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01092780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.