Safety and Efficacy Study in Primary Insomnia Patients- Study A (4305-028) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT01097616

Purpose

This is a multicenter study to test the hypothesis that suvorexant (MK4305) 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. Patients who complete the initial 3-month treatment period may participate in an optional 3-month extension period.

Condition	Intervention	Phase
Primary Insomnia	Drug: Suvorexant (MK4305) Device: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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 A

Further study details as provided by Merck:

Primary Outcome Measures:

Suvorexant high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Suvorexant high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Suvorexant high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Suvorexant low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment:	1023
Study Start Date:	May 2010
Study Completion Date:	December 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Suvorexant High Dose Drug	Drug: Suvorexant (MK4305) Suvorexant 40 mg + matching PBO for patients < 65 years old; Suvorexant 30 mg + matching PBO for patients >= 65 years old. Other Name: MK4305
Experimental: Suvorexant Low Dose Drug	Drug: Suvorexant (MK4305) Suvorexant 20 mg + matching PBO for patients < 65 years old; Suvorexant 15 mg + matching PBO for patients >= 65 years old. Other Name: MK4305
Placebo Comparator: Placebo Placebo Comparator	Device: Comparator: Placebo Matching placebo to suvorexant doses, respectively.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be >=18 yrs old on the day of signing informed consent
Diagnosed with Primary Insomnia
Patient is in good physical and mental health
Patient >=65 yrs old score at least 25 on the Mini Mental State Exam
A female patient who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
Patient reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
Patient reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
The patient's regular bedtime is between 9 pm-1 am
Patient is willing to refrain from napping while in study
Patient is able to read, understand and complete questionnaires and all diaries
Patient is willing to limit alcohol, caffeine, and nicotine consumption while in the study
For a portion of patients: Patient 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 patient 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 ECG at Prestudy Visit
Patient taking certain prohibited medications
Patient consumes the equivalent of >15 cigarettes a day
Patient has a history of malignancy <= 5 years prior to signing informed consent, with the exception of basal cell or squamous cell skin cancer if adequately treated
Patient is considered morbidly obese
Patient was previously randomized in another investigational study of suvorexant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097616

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01097616 History of Changes
Other Study ID Numbers:	2010_520, MK4305-028
Study First Received:	March 26, 2010
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on February 21, 2012