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

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:

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

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
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 May 19, 2013