Clinical trial NCT00620659: 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)
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Hypopnea Syndrome
Excessive Daytime Sleepiness
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
timeFrame: At Week 2
Secondary outcomes:
measure: Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
timeFrame: At Week 2
measure: Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
timeFrame: At Week 2
measure: Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
timeFrame: At Week 2
measure: Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
timeFrame: At Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.