Primary InsomniaPhase 3NCT00094627
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
A Phase 3 study testing gaboxadol in people with Primary Insomnia, run by H. Lundbeck A/S.
Trial summary
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- gaboxadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 465 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with a diagnosis of primary insomnia and in good physical and mental health
Who cannot join
- Adult patients with other medical , neurological and sleep disorders
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.
- Conditions
- Primary Insomnia
- Being tested
- gaboxadol, Comparator: placebo (unspecified)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaboxadolDrug
Also called MK0928
Duration of Treatment - 6 weeks
Comparator: placebo (unspecified)Drug
Duration of Treatment - 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time spent awake and time to fall asleep at night after 2 days
Measured: After 2 days
Secondary outcomes (2)
Amount of time spent awake and time to fall asleep at night after 30 days
Measured: After 30 days
Amount of deep sleep after 2 days
Measured: After 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2004 (estimated)
- Study startNov 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094627
- Sponsor's protocol ID
- 0928-004
- Other IDs
- MK0928-004, 2004_087
- Status last verified
- Jan 2015
- First submitted
- 21 Oct 2004
- Last updated
- 14 Jan 2015
- Results posted
- No
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.
PubMed 18853933Svetnik 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.
PubMed 31926466
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00094627
- Acronym / sponsor ID
- 0928-004
- Conditions
- Primary Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients with a diagnosis of primary insomnia and in good physical and mental health
Key exclusion criteria (1 listed)
- Adult patients with other medical , neurological and sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gaboxadolAlso: MK0928Duration of Treatment - 6 weeks | Drug | – |
| Comparator: placebo (unspecified)Duration of Treatment - 6 weeks | Drug | – |
Primary outcome
Amount of time spent awake and time to fall asleep at night after 2 days
Time frame: After 2 days
2 secondary outcomes
Amount of time spent awake and time to fall asleep at night after 30 days
Time frame: After 30 days
Amount of deep sleep after 2 days
Time frame: After 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Background: PubMed 18853933Lankford 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.
- Derived from this study: PubMed 31926466Svetnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gaboxadol in people with Primary Insomnia, run by H. Lundbeck A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of time spent awake and time to fall asleep at night after 2 days (time frame: After 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094627, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.