Back to resultsAdult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
gaboxadol
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia
Eligibility Criteria
Inclusion Criteria: Adult patients with a diagnosis of primary insomnia and in good physical and mental health Exclusion Criteria: Adult patients with other medical , neurological and sleep disorders
Sites / Locations
Outcomes
Primary Outcome Measures
Amount of time spent awake and time to fall asleep at night after 2 days
Secondary Outcome Measures
Amount of time spent awake and time to fall asleep at night after 30 days
Amount of deep sleep after 2 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00094627
Brief Title
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gaboxadol
Other Intervention Name(s)
MK0928
Intervention Description
Duration of Treatment - 6 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
Duration of Treatment - 6 weeks
Primary Outcome Measure Information:
Title
Amount of time spent awake and time to fall asleep at night after 2 days
Time Frame
After 2 days
Secondary Outcome Measure Information:
Title
Amount of time spent awake and time to fall asleep at night after 30 days
Time Frame
After 30 days
Title
Amount of deep sleep after 2 days
Time Frame
After 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with a diagnosis of primary insomnia and in good physical and mental health
Exclusion Criteria:
Adult patients with other medical , neurological and sleep disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18853933
Citation
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.
Results Reference
background
PubMed Identifier
31926466
Citation
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.
Results Reference
derived
Learn more about this trial
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
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