Phase 3
Completed N=419
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
Source: ClinicalTrials.gov NCT00506389 ↗Enrolled (actual)
419
Serious AEs
0.1%
Results posted
Aug 2014
Primary outcomePrimary: Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period — 45.6; 45.5; 76.1 Minutes
Summary
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period |
45.6; 45.5; 76.1 | — |
| SECONDARY Average Latency to Persistent Sleep (LPS) During the In-Treatment Period |
28.7; 26.1; 40.5 | — |
| SECONDARY Average Subjective Total Sleep Time (TST) During the In-Treatment Period |
384.6; 384.6; 351.6 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of chronic primary insomnia
Exclusion Criteria
- Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
- Has significant medical or psychiatric illness as causing the sleep disorder
- Diagnosed with major depressive disorder
- Substance abuse within the past year
- Night worker or work on rotating shifts
- Has had serious head injury, stroke, epilepsy
- Has a history of bipolar disorder or family (immediate family) history of suicide
- Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
- Drinks beverages containing more than 500 mg caffeine per day
Data sourced from ClinicalTrials.gov (NCT00506389). 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. Informational only — not medical advice.