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Pharmacodynamics and Efficacy of MK7288 (MK-7288-010)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01092780
First received: March 23, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 MK7288 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).


Condition Intervention Phase
Apnea, Sleep
Drug: MK7288
Drug: placebo to MK-7288
Drug: modafinil
Drug: placebo to modafinil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK7288 in Sleep Apnea Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean sleep latency score on the Maintenance of Wakefulness Test (MWT) for participants taking MK-7288 versus placebo [ Time Frame: Baseline, 1,3,5, and 7 hours post dose ] [ Designated as safety issue: No ]
  • Mean score on Standard Deviation of Lane Position (SDLP) driving test for participants taking MK-7288 versus placebo [ Time Frame: Baseline, 2, 4, and 6 hours post dose ] [ Designated as safety issue: No ]
  • Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Baseline through Day 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean sleep latency score on the MWT for participants taking MK-7288 versus modafinil [ Time Frame: Baseline, 1,3,5, and 7 hours post dose ] [ Designated as safety issue: No ]
  • Mean sleep latency score on the MWT for participants taking modafinil versus placebo [ Time Frame: Baseline, 1,3,5, and 7 hours post dose ] [ Designated as safety issue: No ]
  • Mean score on SDLP driving test for participants taking modafinil versus placebo [ Time Frame: Baseline, 2, 4, and 6 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1
MK-7288 10 mg/placebo to MK-7288 20 mg/placebo to modafinil 200 mg
Drug: MK7288
10 mg capsule, orally, single dose
Drug: MK7288
two 10 mg capsules, orally, single dose
Drug: placebo to MK-7288
one or two capsules, orally, single dose
Drug: modafinil
two 100 mg tablets, orally, single dose
Other Name: Provigil®
Drug: placebo to modafinil
two 100 mg tablets, orally, single dose
Experimental: Treatment Sequence 2
MK-7288 20 mg/placebo to MK-7288 10 mg/placebo to modafinil 200 mg
Drug: MK7288
10 mg capsule, orally, single dose
Drug: MK7288
two 10 mg capsules, orally, single dose
Drug: placebo to MK-7288
one or two capsules, orally, single dose
Drug: modafinil
two 100 mg tablets, orally, single dose
Other Name: Provigil®
Drug: placebo to modafinil
two 100 mg tablets, orally, single dose
Experimental: Treatment Sequence 3
modafinil 200 mg/placebo to MK-7288 10 mg/placebo to MK-7288 20 mg
Drug: MK7288
10 mg capsule, orally, single dose
Drug: MK7288
two 10 mg capsules, orally, single dose
Drug: placebo to MK-7288
one or two capsules, orally, single dose
Drug: modafinil
two 100 mg tablets, orally, single dose
Other Name: Provigil®
Drug: placebo to modafinil
two 100 mg tablets, orally, single dose
Experimental: Treatment Sequence 4
placebo to MK-7288 10 mg/placebo to MK-7288 20 mg/placebo to modafinil 200 mg
Drug: MK7288
10 mg capsule, orally, single dose
Drug: MK7288
two 10 mg capsules, orally, single dose
Drug: placebo to MK-7288
one or two capsules, orally, single dose
Drug: modafinil
two 100 mg tablets, orally, single dose
Other Name: Provigil®
Drug: placebo to modafinil
two 100 mg tablets, orally, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 five 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 one 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092780

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01092780     History of Changes
Other Study ID Numbers: 7288-010, MK-7288-010
Study First Received: March 23, 2010
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 25, 2014