Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

• Status: Completed
• Trial end date: 2011-12-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Must be ≥18 yrs old on the day of signing informed consent

• Diagnosed with Primary Insomnia

• Good physical and mental health

• Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination

• A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception

• Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)

• Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1

• Regular bedtime is between 9 pm-1 am

• Willing to refrain from napping while in study

• Able to read, understand and complete questionnaires and all diaries

• Willing to limit alcohol, caffeine, and nicotine consumption while in the study

• For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory

Exclusion Criteria:

• Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study

• History or diagnosis of another sleep disorder

• Difficulty sleeping due to a medical condition

• History of a neurological disorder

• History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication

• Ongoing depression

• History of substance abuse or dependence

• History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit

• Taking certain prohibited medications

• Consumption of the equivalent of >15 cigarettes a day

• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

• Participant is considered morbidly obese

• Previously randomized in another investigational study of suvorexant