Primary InsomniaPhase 2NCT01021852

Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

A Phase 2 study testing MK-6096 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.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Primary Insomnia
What is being tested?: MK-6096
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: No sites listed yet
Study dates: 30 Nov 2009to 1 Feb 2011
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

Participant is willing to stay overnight at a sleep laboratory on 6 separate nights and is willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Participant's regular bedtime is between 9 PM and 12 AM (midnight)
Participant is able to read and complete questionnaires and diaries
Participant is willing to refrain from napping during the study

Who cannot join

If female, participant is breast feeding, pregnant, or planning to become pregnant
Participant is expecting to donate eggs or sperm during the study
Participant has any history of a neurological disorder
Participant has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.
Participant has difficulty sleeping due to a medical condition
Participant has donated blood products within the 8 weeks prior to the study
Participant plans to travel across 3 or more time zones during the study
Participant is currently participating or has participated in a study with an investigational compound or device within the last 30 days

About this study

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).

Conditions: Primary Insomnia
Being tested: MK-6096, Dose-matched Placebo to MK-6096
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.

MK-6096Drug
MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.
Dose-matched Placebo to MK-6096Drug
Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.

Study groups in NCT01021852
Study group	Role	What they receive
MK-6096 2.5 mg/Placebo	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
Placebo/MK-6096 2.5 mg	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
MK-6096 5 mg/Placebo	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
Placebo/MK-6096 5 mg	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
MK-6096 10 mg/Placebo	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
Placebo/MK-6096 10 mg	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
MK-6096 20 mg/Placebo	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096
Placebo/MK-6096 20 mg	Experimental	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime. Receives: Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096

What is being measured

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

Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R\&K) criteria and PSG data were read by a Central Reader. 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 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. Least squares (LS) mean SE was reported for each treatment arm.
Measured: Night 1 and end of Week 4
Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Measured: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)
Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Measured: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)

Secondary outcomes (2)

Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R\&K criteria and PSG data were read by a Central Reader. 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. LS mean WASO was reported for each treatment arm.
Measured: Night 1 and end of Week 4
Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R\&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R\&K scoring. LS mean LPS was reported for each treatment arm.
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.

30 Nov 20091 Feb 2011

First posted30 Nov 2009 (estimated)
Study start30 Nov 2009
Primary completion1 Feb 2011
Study completion1 Feb 2011

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: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01021852
Sponsor's protocol ID: 6096-011
Other IDs: MK-6096-011
Status last verified: Oct 2018
First submitted: 25 Nov 2009
Last updated: 6 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Connor KM, Mahoney E, Jackson S, Hutzelmann J, Zhao X, Jia N, Snyder E, Snavely D, Michelson D, Roth T, Herring WJ. A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia. Int J Neuropsychopharmacol. 2016 Aug 12;19(8):pyw022. doi: 10.1093/ijnp/pyw022. Print 2016 Aug.
PubMed 26979830

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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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 the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia
ClinicalTrials.gov ID: NCT01021852
Acronym / sponsor ID: 6096-011
Conditions: Primary Insomnia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 Nov 2009 (actual)
Primary completion: 1 Feb 2011 (actual)
Study completion: 1 Feb 2011 (actual)
First posted: 30 Nov 2009 (estimated)
Results: Posted 15 Jun 2016

Clinical summary

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

Study design

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

Arm	Type	Receives
MK-6096 2.5 mg/Placebo	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
Placebo/MK-6096 2.5 mg	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
MK-6096 5 mg/Placebo	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
Placebo/MK-6096 5 mg	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
MK-6096 10 mg/Placebo	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
Placebo/MK-6096 10 mg	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
MK-6096 20 mg/Placebo	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
Placebo/MK-6096 20 mg	Experimental	Drug: MK-6096, Drug: Dose-matched Placebo to MK-6096Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.

Who may qualify

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

Key inclusion criteria (4 listed)

Participant is willing to stay overnight at a sleep laboratory on 6 separate nights and is willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Participant's regular bedtime is between 9 PM and 12 AM (midnight)
Participant is able to read and complete questionnaires and diaries
Participant is willing to refrain from napping during the study

Key exclusion criteria (8 listed)

If female, participant is breast feeding, pregnant, or planning to become pregnant
Participant is expecting to donate eggs or sperm during the study
Participant has any history of a neurological disorder
Participant has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.
Participant has difficulty sleeping due to a medical condition

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
MK-6096MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.	Drug	MK-6096 10 mg/Placebo, MK-6096 2.5 mg/Placebo, MK-6096 20 mg/Placebo, MK-6096 5 mg/Placebo, Placebo/MK-6096 10 mg, Placebo/MK-6096 2.5 mg, Placebo/MK-6096 20 mg, Placebo/MK-6096 5 mg
Dose-matched Placebo to MK-6096Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.	Drug	MK-6096 10 mg/Placebo, MK-6096 2.5 mg/Placebo, MK-6096 20 mg/Placebo, MK-6096 5 mg/Placebo, Placebo/MK-6096 10 mg, Placebo/MK-6096 2.5 mg, Placebo/MK-6096 20 mg, Placebo/MK-6096 5 mg

Primary outcome

Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
Time frame: Night 1 and end of Week 4
SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R\&K) criteria and PSG data were read by a Central Reader. 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 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. Least squares (LS) mean SE was reported for each treatment arm.
Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2
Time frame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2
Time frame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.

2 secondary outcomes

Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
Time frame: Night 1 and end of Week 4
Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
Time frame: Night 1 and end of Week 4

Results and safety

Results posted to the registry on 15 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-6096 2.5 mg/Placebo	40	37
Placebo/MK-6096 2.5 mg	40	39
MK-6096 5 mg/Placebo	41	39
Placebo/MK-6096 5 mg	40	38
MK-6096 10 mg/Placebo	42	39
Placebo/MK-6096 10 mg	41	39
MK-6096 20 mg/Placebo	41	41
Placebo/MK-6096 20 mg	41	40

Primary outcome: Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment

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

Measure	Placebo n = 313	MK-6096 2.5 mg n = 79	MK-6096 5 mg n = 78	MK-6096 10 mg n = 80	MK-6096 20 mg n = 80
Night 1 (n=313, 79, 78, 80, 80)	74.8 (0.71)	83.3 (1.54)	84.8 (1.55)	85.6 (1.53)	88.2 (1.53)
Week 4 (n=300, 76, 76, 76, 75)	77.0 (0.71)	81.6 (1.42)	81.1 (1.42)	86.7 (1.43)	85.7 (1.43)

Placebo vs MK-6096 2.5 mg: Difference in LS Means: 8.4 (95% CI 5.3 to 11.5), p <0.001, Mixed Models Analysis
Placebo vs MK-6096 5 mg: Difference in LS Means: 9.9 (95% CI 6.8 to 13.1), p <0.001, Mixed Models Analysis
Placebo vs MK-6096 10 mg: Difference in LS Means: 10.7 (95% CI 7.7 to 13.8), 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 SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.

Primary outcome: Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2

Time frame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total). Number. Unit: percentage of participants

Measure	Placebo n = 315	MK-6096 2.5 mg n = 79	MK-6096 5 mg n = 78	MK-6096 10 mg n = 80	MK-6096 20 mg n = 81
Value	26.0	26.6	25.6	32.5	34.6

Placebo vs MK-6096 2.5 mg: Mean Difference (Final Values): 0.6 (95% CI -9.5 to 12.2)
Placebo vs MK-6096 5 mg: Mean Difference (Final Values): -0.4 (95% CI -10.3 to 11.2)
Placebo vs MK-6096 10 mg: Mean Difference (Final Values): 6.5 (95% CI -4.2 to 18.3)

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.

Primary outcome: Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2

Time frame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total). Number. Unit: percentage of participants

Measure	Placebo n = 315	MK-6096 2.5 mg n = 79	MK-6096 5 mg n = 78	MK-6096 10 mg n = 80	MK-6096 20 mg n = 81
Value	2.2	5.1	1.3	2.5	0.0

Placebo vs MK-6096 2.5 mg: Mean Difference (Final Values): 2.8 (95% CI -1.0 to 10.2)
Placebo vs MK-6096 5 mg: Mean Difference (Final Values): -0.9 (95% CI -3.6 to 4.8)
Placebo vs MK-6096 10 mg: Mean Difference (Final Values): 0.3 (95% CI -2.7 to 6.6)

Population analysed: APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of first dose through follow-up (up to 86 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 315 (0%)	21 of 315 (6.7%)	Not reported
MK-6096 2.5 mg	1 of 79 (1.3%)	3 of 79 (3.8%)	Not reported
MK-6096 5 mg	1 of 78 (1.3%)	5 of 78 (6.4%)	Not reported
MK-6096 10 mg	1 of 80 (1.3%)	10 of 80 (12.5%)	Not reported
MK-6096 20 mg	0 of 81 (0%)	14 of 81 (17.3%)	Not reported
Washout	1 of 315 (0.3%)	5 of 315 (1.6%)	Not reported
Post-Study/Follow-up	1 of 324 (0.3%)	0 of 324 (0%)	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 26979830Connor KM, Mahoney E, Jackson S, Hutzelmann J, Zhao X, Jia N, Snyder E, Snavely D, Michelson D, Roth T, Herring WJ. A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia. Int J Neuropsychopharmacol. 2016 Aug 12;19(8):pyw022. doi: 10.1093/ijnp/pyw022. Print 2016 Aug.
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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-6096 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 8 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 15 Jun 2016). 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?

Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment (time frame: Night 1 and end of Week 4). The study lists 3 primary outcomes in all. 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 NCT01021852, 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.