Primary InsomniaPhase 2NCT00266357
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
A Phase 2 study testing MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose) in people with Primary Insomnia, run by H. Lundbeck A/S.
Trial summary
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Mar 2007
- Phase
- Phase 2
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a diagnosis of primary insomnia
Who cannot join
- Patients with an active psychiatric disorder other than primary insomnia
About this study
Official title: MK0928 Phase II Sleep Laboratory Study - Primary Insomnia
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
- Conditions
- Primary Insomnia
- Being tested
- MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose), Placebo / Duration of Treatment: 2 days for screening period
- 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, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)Drug
Placebo / Duration of Treatment: 2 days for screening periodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of total sleep time over 2 nights.
Secondary outcomes (1)
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startNov 2005
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 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
- NCT00266357
- Sponsor's protocol ID
- 0928-041
- Other IDs
- 2005_107
- Status last verified
- Jan 2015
- First submitted
- 14 Dec 2005
- 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
- MK0928 Phase II Sleep Laboratory Study - Primary Insomnia
- ClinicalTrials.gov ID
- NCT00266357
- Acronym / sponsor ID
- 0928-041
- Conditions
- Primary Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- First posted
- 16 Dec 2005 (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.
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of primary insomnia
Key exclusion criteria (1 listed)
- Patients with an active psychiatric disorder other than primary insomnia
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, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose) | Drug | – |
| Placebo / Duration of Treatment: 2 days for screening period | Drug | – |
Primary outcome
Mean of total sleep time over 2 nights.
1 secondary outcome
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
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.
Related trials for Primary Insomnia
Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
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 2 study testing MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose) 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: 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean of total sleep time over 2 nights.. 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.