A Long Term Safety Study of MK4305 in Patients With Primary Insomnia (4305-009 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021813
First received: November 25, 2009
Last updated: July 2, 2012
Last verified: June 2012
  Purpose

This study will establish the safety and tolerability of MK-4305 when administered for up to 14 months. Participants will be randomized to receive MK-4305 or placebo for a 12-month double-blind treatment phase. Participants who complete the 12-month double-blind treatment phase will enter a 2-month double-blind run-out. At the time of initial randomization, patients assigned to receive MK-4305 during the initial 12-month treatment phase will be simultaneously randomized, in a 1:1 ratio, to receive either MK-4305 or placebo during the 2-month run-out phase. Patients randomized to receive placebo in the initial 12-month treatment phase will continue to receive placebo during the 2-month run-out phase.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety 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, Long Term Safety Study of MK4305 in Patients With Primary Insomnia

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

Primary Outcome Measures:
  • Percentage of participants who experience cataplexy [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience sleep onset paralysis [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience complex sleep-related behaviors [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience falls [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience suicidal ideation and/or behaviors [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience hypnagogic/hypnopompic hallucinations [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience events associated with potential for abuse [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants with withdrawal symptoms [ Time Frame: First 3 days following start of 2-month double-blind run-out ] [ Designated as safety issue: Yes ]
  • Rebound insomnia: Percentage of participants with change from baseline <0 in subjective total sleep time (sTST) at run-out night [ Time Frame: Baseline and first 3 days following start of 2-month double-blind run-out ] [ Designated as safety issue: Yes ]
  • Rebound insomnia: Percentage of participants with change from baseline >0 in subjective time to sleep onset (sTSO) at run-out night [ Time Frame: Baseline and first 3 days following start of 2-month double-blind run-out ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline in sTST after 1st month of treatment [ Time Frame: Baseline and Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Mean change from baseline in sTSO after the first month of treatment [ Time Frame: Baseline and Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]

Enrollment: 782
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-4305
12-month double-blind treatment phase - MK-4305; 2-month double-blind run-out - MK-4305 or placebo in a 1:1 ratio
Drug: MK4305
MK4305 daily before bedtime
Other Name: MK4305
Drug: Comparator: Placebo to MK4305
Placebo to MK4305 daily before bedtime
Placebo Comparator: Placebo
12-month double-blind treatment phase and 2-month double-blind run-out - placebo
Drug: Comparator: Placebo to MK4305
Placebo to MK4305 daily before bedtime

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of primary insomnia
  • Participant is able to read, understand, and complete questionnaires and diaries
  • If female, participant agrees to use acceptable contraception

Exclusion Criteria:

  • If female, participant is pregnant
  • Participant expects to donate eggs or sperm during the study
  • Recent and/or active history of a confounding neurological disorder
  • History of clinically unstable cardiovascular disorder within the last 6 months
  • History of bipolar disorder
  • Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the patient's ability to participate in the study
  • History of substance abuse/dependence
  • History of cancer except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • History of uncontrolled diabetes
  • Participant has travelled across >3 time zones or >3 hour time difference in the last 2 weeks
  • History of permanent night shift work or rotating day/night shift work in the past 2 weeks
  • Body Mass Index (BMI) >40 kg/m^2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021813

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: NCT01021813     History of Changes
Other Study ID Numbers: 4305-009, MK-4305-009, 2009_696
Study First Received: November 25, 2009
Last Updated: July 2, 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 April 17, 2014