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

Sponsor:	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

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.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Modafinil

U.S. FDA Resources

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 ]

Enrollment:	200
Study Start Date:	February 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00620659 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Physiological Effects of Drugs
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias
Sleep Disorders
Central Nervous System Stimulants
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Modafinil
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Syndrome
Signs and Symptoms, Respiratory
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009