NCT00102167

Brief Summary

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
663

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2005

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

First QC Date

January 21, 2005

Last Update Submit

January 13, 2015

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Amount of time spent awake and time to fall asleep during one night

    one night

Secondary Outcomes (2)

  • Amount of deep sleep during one night.

    one night

  • Patient-reported sleep quality and awakenings during 1 night.

    one night

Interventions

gaboxadolDRUG

Duration of Treatment -1 day

Also known as: MK0928

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults who are between the ages of 18 and 64

You may not qualify if:

  • Adults who are diagnosed with insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. doi: 10.1016/j.sleep.2007.06.006. Epub 2007 Aug 30.

    PMID: 17765013BACKGROUND

  • Ma J, Dijk DJ, Svetnik V, Tymofyeyev Y, Ray S, Walsh JK, Deacon S. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med. 2011 Oct 15;7(5):493-501A. doi: 10.5664/JCSM.1316.

    PMID: 22003345DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

gaboxadol

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2005

First Posted

January 24, 2005

Study Start

February 1, 2005

Study Completion

December 1, 2005

Last Updated

January 14, 2015

Record last verified: 2015-01