NCT00094627

Brief Summary

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
465

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2004

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

October 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2004

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

First QC Date

October 21, 2004

Last Update Submit

January 13, 2015

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

  • Amount of time spent awake and time to fall asleep at night after 2 days

    After 2 days

Secondary Outcomes (2)

  • Amount of time spent awake and time to fall asleep at night after 30 days

    After 30 days

  • Amount of deep sleep after 2 days

    After 2 days

Interventions

gaboxadolDRUG

Duration of Treatment - 6 weeks

Also known as: MK0928
Comparator: placebo (unspecified)DRUG

Duration of Treatment - 6 weeks

Eligibility Criteria

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

You may qualify if:

  • Adult patients with a diagnosis of primary insomnia and in good physical and mental health

You may not qualify if:

  • Adult patients with other medical , neurological and sleep disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct;31(10):1359-70.

    PMID: 18853933BACKGROUND

  • Svetnik V, Snyder ES, Tao P, Roth T, Lines C, Herring WJ. How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients? Sleep Med. 2020 Mar;67:137-146. doi: 10.1016/j.sleep.2019.08.020. Epub 2019 Sep 11.

    PMID: 31926466DERIVED

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

October 21, 2004

First Posted

October 22, 2004

Study Start

November 1, 2004

Study Completion

April 1, 2006

Last Updated

January 14, 2015

Record last verified: 2015-01