Sleep Initiation and Maintenance DisordersPhase 3NCT00750919

Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

A Phase 3 study testing esmirtazapine in people with Sleep Initiation and Maintenance Disorders and Mental Disorders, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias
What is being tested?: esmirtazapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: No sites listed yet
Study dates: 7 Oct 2008to 10 Mar 2010
Phase: Phase 3
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign written informed consent
Completed clinical trial 21106/P05701/MK-8265-002

Who cannot join

Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
Pregnancy

About this study

Official title: A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106

Conditions: Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders, Sleep Disorders, Intrinsic
Being tested: esmirtazapine
Medical subject headings: Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Wake Disorders, Sleep Disorders, Intrinsic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

esmirtazapineDrug

Study groups in NCT00750919
Study group	Role	What they receive
Esmirtazapine	Experimental	Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months. Receives: Drug: esmirtazapine

What is being measured

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

Change From Baseline in Total Sleep Time (TST)
TST was defined as the time recorded for sleep diary question 6 "how much time did you actually spend sleeping" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Measured: Baseline and Week 26
Number of Participants Experiencing Adverse Events (AEs)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 30 weeks
Number of Participants Discontinuing Due to AEs
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 26 weeks

Secondary outcomes (2)

Change From Baseline in Sleep Latency (SL)
SL was defined as the time recorded for sleep diary question 3 "how long did it take you to fall asleep', " as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Measured: Baseline and Week 26
Change From Baseline in Wake Time After Sleep Onset (WASO)
WASO was defined as the time recorded for sleep diary question 5 "how much time were you awake, after falling asleep initially" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Measured: Baseline and Week 26

Timeline

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

7 Oct 200810 Mar 2010

First posted11 Sep 2008 (estimated)
Study start7 Oct 2008
Primary completion10 Mar 2010
Study completion10 Mar 2010

Why it stopped: This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.

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 Initiation and Maintenance DisordersStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00750919
Sponsor's protocol ID: P05721
Other IDs: 176003, 2007-005237-10
Status last verified: Jan 2021
First submitted: 10 Sep 2008
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.
PubMed 32351205

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 Sleep Initiation and Maintenance Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106
ClinicalTrials.gov ID: NCT00750919
Acronym / sponsor ID: P05721
Conditions: Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders, Sleep Disorders, Intrinsic
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.
Enrolment: 184 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 7 Oct 2008 (actual)
Primary completion: 10 Mar 2010 (actual)
Study completion: 10 Mar 2010 (actual)
First posted: 11 Sep 2008 (estimated)
Results: Posted 24 Jun 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Esmirtazapine	Experimental	Drug: esmirtazapineParticipants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Sign written informed consent
Completed clinical trial 21106/P05701/MK-8265-002

Key exclusion criteria (3 listed)

Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
Pregnancy

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
esmirtazapine	Drug	Esmirtazapine

Primary outcome

Change From Baseline in Total Sleep Time (TST)
Time frame: Baseline and Week 26
TST was defined as the time recorded for sleep diary question 6 "how much time did you actually spend sleeping" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 30 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Number of Participants Discontinuing Due to AEs
Time frame: Up to 26 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

2 secondary outcomes

Change From Baseline in Sleep Latency (SL)
Time frame: Baseline and Week 26
Change From Baseline in Wake Time After Sleep Onset (WASO)
Time frame: Baseline and Week 26

Results and safety

Results posted to the registry on 24 Jun 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
Esmirtazapine	184	126

Primary outcome: Change From Baseline in Total Sleep Time (TST)

Time frame: Baseline and Week 26. Mean (Standard Deviation). Unit: Minutes per night

Measure	Esmirtazapine n = 184
Baseline measure (n=184)	368.1 (91.5)
Change from baseline at Week 26 (n=123)	9.7 (56.1)

Population analysed: The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.

Primary outcome: Number of Participants Experiencing Adverse Events (AEs)

Time frame: Up to 30 weeks. Number. Unit: Participants

Measure	Esmirtazapine n = 184
Value	127

Population analysed: The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.

Primary outcome: Number of Participants Discontinuing Due to AEs

Time frame: Up to 26 weeks. Number. Unit: Participants

Measure	Esmirtazapine n = 184
Value	9

Population analysed: The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Nonserious AEs were collected from first dispensing of study drug up to 7 days after last dose of study drug. Serious AEs were collected from first dispensing of study drug up to 30 days after last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esmirtazapine	3 of 184 (1.6%)	59 of 184 (32.1%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated due to the Sponsor's decision not to continue development of esmertazapine for this indication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32351205Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing esmirtazapine in people with Sleep Initiation and Maintenance Disorders and Mental Disorders, 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 2 inclusion and 3 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 2 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 24 Jun 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?

Change From Baseline in Total Sleep Time (TST) (time frame: Baseline and Week 26). 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 NCT00750919, 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 2 Feb 2021.