Phase 3
N=460
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Sleep Initiation and Maintenance Disorders · Mental Disorders · Dyssomnias · Sleep Disorders · Sleep Disorder, Intrinsic
Bottom Line
View on ClinicalTrials.gov: NCT00631657 ↗Enrolled (actual)
460
Serious AEs
2.2%
Results posted
Aug 2014
Primary outcome: Primary: Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period — 65.9; 19.3 minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esmirtazapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period |
65.9; 19.3 | <0.0001 sig |
| SECONDARY Number of Participants Who Experienced Adverse Events (AEs) |
253; 75 | — |
| SECONDARY Number of Participants Who Discontinued Study Drug Due to an AE |
47; 7 | — |
| SECONDARY Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period |
-29.7; -26.9 | 0.2145 |
| SECONDARY Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period |
-46.4; -20.8 | <0.0001 sig |
Summary
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).
Eligibility Criteria
Inclusion Criteria
- are at least 18 and less than 65 years;
- sign written informed consent after the scope and nature of the investigation have been explained;
- have shown capability to complete the LogPad questionnaires;
- have difficulty falling asleep, maintaining sleep or have early morning awakening;
Exclusion Criteria
- Significant medical or psychiatric illness causing sleep disturbances.
- Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
- Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
- Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
- Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
- Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
- Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
- Routinely nap during the day.
- Have a Body Mass Index (BMI) of 36 or more.
Data sourced from ClinicalTrials.gov (NCT00631657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.