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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014