Primary InsomniaPhase 2NCT00792298

Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

A Phase 2 study testing Suvorexant in people with Primary Insomnia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary 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?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: No sites listed yet
Study dates: 5 Nov 2008to 26 Dec 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

Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
Must be willing to stay overnight at a sleep laboratory
Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Regular bedtime is between 9 PM and 12 AM (midnight)

Who cannot join

Breast feeding, pregnant or planning to become pregnant during the study
Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
Currently participating or have participated in a study with an investigational compound or device within the last 30 days
Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
Has done shift work within the past 2 weeks
Has donated blood products within the last 8 weeks
Has difficulty sleeping due to a medical condition

About this study

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK-4305 in Patients With Primary Insomnia

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Conditions: Primary Insomnia
Being tested: Suvorexant, Dose-matched Placebo to Suvorexant
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.

SuvorexantDrug
Also called MK-4305
oral tablet taken before bedtime
Dose-matched Placebo to SuvorexantDrug
Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Study groups in NCT00792298
Study group	Role	What they receive
Suvorexant 10 mg → Placebo	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Placebo → Suvorexant 10 mg	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Suvorexant 20 mg → Placebo	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Placebo → Suvorexant 20 mg	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Suvorexant 40 mg → Placebo	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Placebo → Suvorexant 40 mg	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Suvorexant 80 mg → Placebo	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Placebo → Suvorexant 80 mg	Experimental	After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

What is being measured

The primary outcome is the main question the study is designed to answer.

LS Mean Sleep Efficiency (SE) During Periods 1 and 2
SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100
Measured: Night 1 and end of Week 4

Secondary outcomes (2)

LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2
WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.
Measured: Night 1 and end of Week 4
LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2
LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.
Measured: Night 1 and end of Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 200826 Dec 2009

First posted17 Nov 2008 (estimated)
Study start5 Nov 2008
Primary completion26 Dec 2009
Study completion26 Dec 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 Primary InsomniaStudies 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: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00792298
Sponsor's protocol ID: 4305-006
Other IDs: 2008_583
Status last verified: Oct 2018
First submitted: 10 Nov 2008
Last updated: 6 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.
PubMed 23197752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Primary Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK-4305 in Patients With Primary Insomnia
ClinicalTrials.gov ID: NCT00792298
Acronym / sponsor ID: 4305-006
Conditions: Primary Insomnia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 5 Nov 2008 (actual)
Primary completion: 26 Dec 2009 (actual)
Study completion: 26 Dec 2009 (actual)
First posted: 17 Nov 2008 (estimated)
Results: Posted 14 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Suvorexant 10 mg → Placebo	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 10 mg	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 20 mg → Placebo	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 20 mg	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 40 mg → Placebo	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 40 mg	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 80 mg → Placebo	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 80 mg	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
Must be willing to stay overnight at a sleep laboratory
Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Regular bedtime is between 9 PM and 12 AM (midnight)

Key exclusion criteria (7 listed)

Breast feeding, pregnant or planning to become pregnant during the study
Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
Currently participating or have participated in a study with an investigational compound or device within the last 30 days
Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
Has done shift work within the past 2 weeks

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
SuvorexantAlso: MK-4305oral tablet taken before bedtime	Drug	Placebo → Suvorexant 10 mg, Placebo → Suvorexant 20 mg, Placebo → Suvorexant 40 mg, Placebo → Suvorexant 80 mg, Suvorexant 10 mg → Placebo, Suvorexant 20 mg → Placebo, Suvorexant 40 mg → Placebo, Suvorexant 80 mg → Placebo
Dose-matched Placebo to SuvorexantDose-matched placebo to suvorexant taken before bedtime (oral tablet)	Drug	Placebo → Suvorexant 10 mg, Placebo → Suvorexant 20 mg, Placebo → Suvorexant 40 mg, Placebo → Suvorexant 80 mg, Suvorexant 10 mg → Placebo, Suvorexant 20 mg → Placebo, Suvorexant 40 mg → Placebo, Suvorexant 80 mg → Placebo

Primary outcome

LS Mean Sleep Efficiency (SE) During Periods 1 and 2
Time frame: Night 1 and end of Week 4
SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100

2 secondary outcomes

LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2
Time frame: Night 1 and end of Week 4
LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2
Time frame: Night 1 and end of Week 4

Results and safety

Results posted to the registry on 14 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suvorexant 10 mg → Placebo	31	30
Placebo → Suvorexant 10 mg	32	31
Suvorexant 20 mg → Placebo	33	31
Placebo → Suvorexant 20 mg	32	28
Suvorexant 40 mg → Placebo	32	32
Placebo → Suvorexant 40 mg	32	29
Suvorexant 80 mg → Placebo	31	27
Placebo → Suvorexant 80 mg	31	30

Primary outcome: LS Mean Sleep Efficiency (SE) During Periods 1 and 2

Time frame: Night 1 and end of Week 4. Least squares mean (Standard Error). Unit: percent of time in bed

Measure	Placebo n = 249	Suvorexant 10 mg n = 62	Suvorexant 20 mg n = 61	Suvorexant 40 mg n = 59	Suvorexant 80 mg n = 61
Night 1 (n=249, 62, 61, 59, 61)	75.8 (0.93)	81.0 (1.75)	83.4 (1.75)	86.6 (1.77)	88.7 (1.77)
Week 4 (n=232, 59, 57, 57, 55)	76.6 (0.94)	81.3 (1.66)	87.0 (1.68)	84.4 (1.68)	84.2 (1.70)

Placebo vs Suvorexant 80 mg: LS Mean Difference: Night 1: 12.9 (95% CI 9.5 to 16.3), p <0.001, Mixed Models Analysis
Placebo vs Suvorexant 80 mg: LS Mean Difference: Week 4: 7.6 (95% CI 4.4 to 10.9), p <0.001, Mixed Models Analysis
Placebo vs Suvorexant 40 mg: LS Mean Difference: Night 1: 10.8 (95% CI 7.4 to 14.2), p <0.001, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 249 (0%)	9 of 249 (3.6%)	Not reported
Suvorexant 10 mg	0 of 62 (0%)	1 of 62 (1.6%)	Not reported
Suvorexant 20 mg	0 of 61 (0%)	4 of 61 (6.6%)	Not reported
Suvorexant 40 mg	0 of 59 (0%)	11 of 59 (18.6%)	Not reported
Suvorexant 80 mg	0 of 61 (0%)	11 of 61 (18%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23197752Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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 Suvorexant in people with Primary Insomnia, 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 4 inclusion and 7 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 6 Nov 2018. 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 14 Nov 2014). 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?

LS Mean Sleep Efficiency (SE) During Periods 1 and 2 (time frame: Night 1 and end of Week 4). 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 NCT00792298, 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 6 Nov 2018.