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

Phase 3TerminatedNCT00750919

Merck Sharp & Dohme LLC184 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic

Interventions

esmirtazapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 26 weeks

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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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.

Time frame: Baseline and Week 26