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)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Hypopnea Syndrome; Sleep Apnea, Obstructive; Excessive Daytime Sleepiness

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620659

0249-015

2007_602

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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125 participants in 6 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249

2

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249

3

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249

4

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249

5

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249

6

Experimental group

Description:

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

Treatment:

Drug: Comparator: placebo

Drug: Comparator: modafinil

Drug: Comparator: MK0249