A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK4305 IN PATIENTS WITH PRIMARY INSOMNIA- STUDY B

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 55 人开始时间: 2010年6月21日最近更新: 2023年9月4日

适应症

试验速览

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•Must be ≥18 years old on the day of signing informed consent
•Diagnosed with Primary Insomnia
•Good physical and mental health
•Participant ≥65 years 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

•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

发起方

MERCK SHARP & DOHME PERU S.R.L.,