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)

NCT ID: NCT00620659

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

2

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

3

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

4

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

5

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

6

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

Group Type: EXPERIMENTAL

Comparator: MK0249

Intervention Type: 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).

Comparator: placebo

Intervention Type: 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.

Comparator: modafinil

Intervention Type: 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.

Interventions

Comparator: MK0249

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).

Intervention Type: 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.

Intervention Type: DRUG

Comparator: modafinil

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 23920422 (View on PubMed)

Other Identifiers

2007_602

Identifier Type: -

Identifier Source: secondary_id

0249-015

Identifier Type: -

Identifier Source: org_study_id