Overview

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