- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00094666
Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)
January 13, 2015 updated by: H. Lundbeck A/S
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia
The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment
465
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elderly patients with a diagnosis of primary insomnia and in good physical and mental health
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Amount of time spent awake and time to fall asleep at night after two days
|
Secondary Outcome Measures
Outcome Measure |
---|
Amount of time spent awake and time to fall asleep at night after 30 days
|
Amount of deep sleep after two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
October 21, 2004
First Submitted That Met QC Criteria
October 21, 2004
First Posted (Estimate)
October 22, 2004
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- GABA Agents
- Anticonvulsants
- GABA Agonists
- Gaboxadol
Other Study ID Numbers
- 0928-002
- MK0928-002
- 2004_085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Insomnia
-
Midnight Pharma, LLCCompletedChronic Primary InsomniaUnited States
-
IWK Health CentreUnknownPrimary Insomnia | Nonorganic InsomniaCanada
-
Oregon Health and Science UniversityCompletedPrimary Insomnia | Psychophysiological InsomniaUnited States
-
University of RochesterSanofi-SynthelaboCompletedInsomnia | Primary Insomnia | Psychophysiologic InsomniaUnited States
-
University of UtahEvans Army Community HospitalCompletedPrimary Insomnia | Secondary InsomniaUnited States
-
US Department of Veterans AffairsCompletedInsomnia | Primary Insomnia | Secondary InsomniaUnited States
-
University of WashingtonUnknownChronic Insomnia | Insomnia, Primary
-
Jack Edinger, PhDMerck Sharp & Dohme LLCCompletedInsomnia | Primary Insomnia | Chronic InsomniaUnited States
-
University of PittsburghCompletedInsomnia Chronic | Insomnia, PrimaryUnited States
-
Eli Lilly and CompanyCompletedAn Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia (SLUMBER)Primary Insomnia | Secondary InsomniaUnited States
Clinical Trials on MK0928, gaboxadol / Duration of Treatment - 6 weeks
-
H. Lundbeck A/STerminated
-
H. Lundbeck A/SCompleted
-
H. Lundbeck A/STerminated
-
H. Lundbeck A/SCompleted
-
H. Lundbeck A/SWithdrawn
-
Organon and CoTerminatedCardiovascular Diseases | Diabetes Mellitus
-
Merck Sharp & Dohme LLCCompleted
-
H. Lundbeck A/SCompleted
-
Organon and CoCompleted