Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)

NCT00620659 | Terminated Phase 2 Results

• 2 other identifiers: 0249-0152007_602
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive; Hypopnea Syndrome; Excessive Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

• Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo

  The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.

  At Week 2

Secondary Outcomes (4)

• Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil

  At Week 2

• Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil

  At Week 2

• Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo

  At Week 2

• Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo

  At Week 2

Study Arms (6)

1

EXPERIMENTAL

Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

2

EXPERIMENTAL

Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

3

EXPERIMENTAL

Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

4

EXPERIMENTAL

Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

5

EXPERIMENTAL

Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

6

EXPERIMENTAL

Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249

Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil

Interventions

Comparator: MK0249 DRUG

Patients will be assigned to receive MK0249 film coated tablet (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, by mouth (po) once a day (qd).

1; 2; 3; 4; 5; 6

Comparator: placebo DRUG

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.

1; 2; 3; 4; 5; 6

Comparator: modafinil DRUG

Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.

  PMID: 23920422 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 13, 2015
• Results First Posted: February 23, 2011

Record last verified: 2015-04