Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00620659

Purpose

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.

Condition	Intervention	Phase
Sleep Apnea, Obstructive Hypopnea Syndrome Excessive Daytime Sleepiness	Drug: Comparator: MK0249 Drug: Comparator: placebo Drug: Comparator: modafinil	Phase II

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Modafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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.

Further study details as provided by Merck:

Primary Outcome Measures:

To determine the effect of MK0249 after 2 weeks of treatment, compared to placebo, on promoting wakefulness. [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the effect of MK0249 after 2 weeks of treatment, compared to modafinil. [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: Treatment period 1: MK0249; Treatment period 2: Pbo; Treatment period 3: modafinil	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
2: Experimental Arm 2: Treatment period 1: Pbo; Treatment period 2: modafinil; Treatment period 3: MK0249	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
3: Experimental Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Pbo	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
4: Experimental Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Pbo	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
5: Experimental Arm 5: Treatment period 1: Pbo; Treatment period 2: MK0249; Treatment period 3: modafinil	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
6: Experimental Arm 6: Treatment period 1: modafinil; Treatment period 2: Pbo; Treatment period 3: MK0249	Drug: Comparator: MK0249 Patients will be assigned to receive MK0249 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, po qd. Drug: Comparator: placebo 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. Drug: Comparator: modafinil Patients will be assigned to receive modfinil 200mg OCT, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620659

Locations

United States, Arizona
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Tucson, Arizona, United States, 86712
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Phoenix, Arizona, United States, 85050
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Phoenix, Arizona, United States, 85006-0000
United States, California
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Standford, California, United States, 94305
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Santa Monica, California, United States, 90404
United States, Florida
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South Miami, Florida, United States, 33143
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Saint Petersburg, Florida, United States, 33707
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Pembroke Pines, Florida, United States, 33026
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Naples, Florida, United States, 34110
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Brandon, Florida, United States, 33511
United States, Georgia
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Atlanta, Georgia, United States, 30342
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kansas
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Overland Park, Kansas, United States, 66212
United States, Kentucky
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Louisville, Kentucky, United States, 40217
United States, Maryland
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Chevy Chase, Maryland, United States, 20815
United States, New York
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New York, New York, United States, 10019
United States, North Carolina
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Greenville, North Carolina, United States, 27835-6028
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cincinnati, Ohio, United States, 45246-0000
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Cincinnati, Ohio, United States, 45227
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
United States, Texas
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Houston, Texas, United States, 77030-0000

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_602, MK0249-015
Study First Received:	January 10, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00620659
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive

Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Modafinil
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009