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

• ClinicalTrials.gov Identifier: NCT00750919
• Recruitment Status: Terminated
• First Posted: September 11, 2008
• Results First Posted: June 24, 2014
• Last Update Posted: February 2, 2021
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

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).

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorders, Intrinsic	Drug: esmirtazapine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 184 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 7, 2008
• Actual Primary Completion Date: March 10, 2010
• Actual Study Completion Date: March 10, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Esmirtazapine; Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.	Drug: esmirtazapine

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Change From Baseline in Sleep Latency (SL) [ Time Frame: Baseline and Week 26 ]
   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.
2. Change From Baseline in Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline and Week 26 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00750919
• Other Study ID Numbers: P05721; 176003 ( Other Identifier: Organon Protocol Number ); 2007-005237-10 ( EudraCT Number )
• First Posted: September 11, 2008
• Results First Posted: June 24, 2014
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Disorders, Intrinsic; Disease; Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Mirtazapine; Antidepressive Agents; Psychotropic Drugs; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Serotonin 5-HT3 Receptor Antagonists