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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT01021813

Purpose

This study will establish the safety and tolerability of MK4305 when administered for up to 14 months.

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

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:

Proportion of patients who experience narcolepsy-like events, including cataplexy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who experience complex sleep-related behavior [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who experience falls [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who experience suicidal ideation and/or behaviors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean change from baseline in subjective total sleep time (sTST) after 1st month of treatment [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
Mean change from baseline in subjective time to sleep onset (sTSO) after the first month of treatment [ Time Frame: 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: 1 MK4305	Drug: MK4305 MK4305 daily before bedtime for up to 14 months. Other Name: MK4305
Placebo Comparator: 2 Placebo	Drug: Comparator: Placebo to MK4305 Placebo to MK4305 daily before bedtime for up to 14 months.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

If female, patient is pregnant
Patient expects to donate eggs or sperm during the study
Patient has any history of a neurological disorder
Patient has a history of clinically unstable cardiovascular disorder within the last 6 months
Patient has a history of bipolar disorder
Patient has a 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
Patient has a history of substance abuse/dependence
Patient has a history of cancer
Patient has a history of uncontrolled diabetes
Patient has travelled across > 3 time zones or > 3 hour time difference in the last 2 weeks
Patient has a history of permanent night shift work or rotating day/night shift work in the past 2 weeks

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01021813 History of Changes
Other Study ID Numbers:	2009_696, MK4305-009
Study First Received:	November 25, 2009
Last Updated:	August 31, 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 February 09, 2012