Sleep Apnea, ObstructivePhase 2NCT00620659
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
A Phase 2 study testing Comparator: MK0249 and Comparator: modafinil in people with Sleep Apnea, Obstructive and Hypopnea Syndrome, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypopnea Syndrome, Excessive Daytime Sleepiness
- What is being tested?
- Comparator: MK0249 and Comparator: modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is male or female and is at least 18 years old and less than 65 years old
- Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
- Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
- Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
- Patient is willing to refrain from napping for the duration of the study
Who cannot join
- Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
- Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
- Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
- Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
About this study
Official title: Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy.
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.
- Being tested
- Comparator: MK0249, Comparator: placebo, Comparator: modafinil
- Medical subject headings
- Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: MK0249Drug
Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).
Comparator: placeboDrug
Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
Comparator: modafinilDrug
Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
| 2 | Experimental | Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
| 3 | Experimental | Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
| 4 | Experimental | Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
| 5 | Experimental | Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
| 6 | Experimental | Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249 Receives: Drug: Comparator: MK0249; Drug: Comparator: placebo; Drug: Comparator: modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
Measured: At Week 2
Secondary outcomes (4)
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.
Measured: At Week 2
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.
Measured: At Week 2
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.
Measured: At Week 2
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 ("would never dose") to 3 ("high chance of dozing"). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse).
Measured: At Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620659
- Sponsor's protocol ID
- 0249-015
- Other IDs
- 2007_602
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2008
- Last updated
- 13 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.
PubMed 23920422
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy.
- ClinicalTrials.gov ID
- NCT00620659
- Acronym / sponsor ID
- 0249-015
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 23 Feb 2011
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 to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil |
| 2 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 |
| 3 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo |
| 4 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo |
| 5 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil |
| 6 | Experimental | Drug: Comparator: MK0249, Drug: Comparator: placebo, Drug: Comparator: modafinilArm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient is male or female and is at least 18 years old and less than 65 years old
- Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
- Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
- Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
- Patient is willing to refrain from napping for the duration of the study
Key exclusion criteria (4 listed)
- Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
- Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
- Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
- Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
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 |
|---|---|---|
| Comparator: MK0249Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd). | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: placeboPlacebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd. | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: modafinilPatients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd. | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
Time frame: At Week 2
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
4 secondary outcomes
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
Time frame: At Week 2
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
Time frame: At Week 2
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
Time frame: At Week 2
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
Time frame: At Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23920422Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.
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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 2 study testing Comparator: MK0249 and Comparator: modafinil in people with Sleep Apnea, Obstructive and Hypopnea Syndrome, run by Merck Sharp & Dohme LLC.
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 4 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 13 May 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?
Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo (time frame: At Week 2). 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 NCT00620659, which also lists 1 linked publication.
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 13 May 2015.