Safety and Efficacy Study in Primary Insomnia Patients-Study B (4305-029)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01097629
First received: March 26, 2010
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

This is a multicenter study to test the hypothesis that MK4305 compared to placebo 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.


Condition Intervention Phase
Primary Insomnia
Drug: MK4305
Drug: Comparator: Placebo
Phase 3

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 B

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • MK4305 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:
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Night 1 ] [ Designated as safety issue: No ]

Enrollment: 1019
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK4305 High Dose
Drug
Drug: MK4305
MK4305 40 mg + matching PBO for patients < 65 years old; MK4305 30 mg + matching PBO for patients >= 65 years old.
Other Name: MK4305
Experimental: MK4305- Low Dose
Drug
Drug: MK4305
MK4305 20 mg + matching PBO for patients < 65 years old; MK4305 15 mg + matching PBO for patients >= 65 years old.
Other Name: MK4305
Placebo Comparator: Placebo
Placebo Comparator
Drug: Comparator: Placebo
Matching placebo to MK4305 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 MK4305
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097629

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01097629     History of Changes
Other Study ID Numbers: 2010_521, MK-4305-029
Study First Received: March 26, 2010
Last Updated: November 22, 2011
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 April 17, 2014