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

Primary Purpose

Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
esmirtazapine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Esmirtazapine

    Arm Description

    Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    September 10, 2008
    Last Updated
    January 19, 2021
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00750919
    Brief Title
    Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Terminated
    Why Stopped
    This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.
    Study Start Date
    October 7, 2008 (Actual)
    Primary Completion Date
    March 10, 2010 (Actual)
    Study Completion Date
    March 10, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders, Sleep Disorders, Intrinsic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Esmirtazapine
    Arm Type
    Experimental
    Arm Description
    Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    esmirtazapine
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Total Sleep Time (TST)
    Description
    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.
    Time Frame
    Baseline and Week 26
    Title
    Number of Participants Experiencing Adverse Events (AEs)
    Description
    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.
    Time Frame
    Up to 30 weeks
    Title
    Number of Participants Discontinuing Due to AEs
    Description
    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.
    Time Frame
    Up to 26 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Sleep Latency (SL)
    Description
    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.
    Time Frame
    Baseline and Week 26
    Title
    Change From Baseline in Wake Time After Sleep Onset (WASO)
    Description
    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.
    Time Frame
    Baseline and Week 26

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign written informed consent Completed clinical trial 21106/P05701/MK-8265-002 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    32351205
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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