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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 184
- Primary Endpoint
- Number of Participants Discontinuing Due to AEs
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Esmirtazapine
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.
Intervention: esmirtazapine (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Change From Baseline in Wake Time After Sleep Onset (WASO)(Baseline and Week 26)
- Change From Baseline in Sleep Latency (SL)(Baseline and Week 26)