Primary InsomniaPhase 3NCT00420810
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
A Phase 3 study testing MK0928 / Duration of Treatment : 8 Weeks in people with Primary Insomnia, run by H. Lundbeck A/S.
Trial summary
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference. 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?
- MK0928 / Duration of Treatment : 8 Weeks
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Mar 2007
- 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
- Diagnosis of Primary Insomnia
- Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
- Patient is willing to avoid alcohol on PSG visits
- Patient will avoid napping during the course of the study
- Patient's bedtime is between 9pm and 1am
Who cannot join
- History of substance abuse, bipolar disorder or psychotic disorder
- Difficulty sleeping due to other medical condition
- History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
- History of neoplastic malignancy within the last 5 years
- Positive alcohol breath test during the screening visits
About this study
Official title: A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.
- Conditions
- Primary Insomnia
- Being tested
- MK0928 / Duration of Treatment : 8 Weeks
- 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.
MK0928 / Duration of Treatment : 8 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake after sleep onset and Latency to persistent sleep
Secondary outcomes (1)
Subjective total sleep time and subjective time to sleep onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 138 participants
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
- NCT00420810
- Sponsor's protocol ID
- 0928-049
- Other IDs
- 2006_514
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2007
- Last updated
- 14 Jan 2015
- Results posted
- No
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, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00420810
- Acronym / sponsor ID
- 0928-049
- Conditions
- Primary Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 138 participants
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 11 Jan 2007 (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 this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Primary Insomnia
- Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
- Patient is willing to avoid alcohol on PSG visits
- Patient will avoid napping during the course of the study
- Patient's bedtime is between 9pm and 1am
Key exclusion criteria (5 listed)
- History of substance abuse, bipolar disorder or psychotic disorder
- Difficulty sleeping due to other medical condition
- History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
- History of neoplastic malignancy within the last 5 years
- Positive alcohol breath test during the screening visits
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 |
|---|---|---|
| MK0928 / Duration of Treatment : 8 Weeks | Drug | – |
Primary outcome
Wake after sleep onset and Latency to persistent sleep
1 secondary outcome
Subjective total sleep time and subjective time to sleep onset
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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 MK0928 / Duration of Treatment : 8 Weeks 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 5 inclusion and 5 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: stopped early, 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 was stopped early. Results are not available in the source record.
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?
Wake after sleep onset and Latency to persistent sleep. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.