Clinical trial NCT01092780: Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
Official title: An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Apnea, Sleep
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo
timeFrame: 1, 3, 5 and 7 hours post dose
measure: Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo
timeFrame: 2, 4 and 6 hours post dose
measure: Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
timeFrame: Up to 36 days
Secondary outcomes:
measure: Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil
timeFrame: 1, 3, 5 and 7 hours post dose
measure: Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo
timeFrame: 1, 3, 5 and 7 hours post dose
measure: Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo
timeFrame: 2, 4 and 6 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.