Phase 3
Completed N=412
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Source: ClinicalTrials.gov NCT00291187 ↗Enrolled (actual)
412
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Average Improvement of Latency to Persistent Sleep (LPS) — 45.8; 24.3; 19.6; 23.1 minutes — p=<0.001
Summary
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Improvement of Latency to Persistent Sleep (LPS) |
45.8; 24.3; 19.6; 23.1 | <0.001 sig |
| SECONDARY Average Improvement of Wake After Sleep Onset (WASO) |
139.3; 115.1; 105.6; 121.9 | 0.017 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects with no medical, psychiatric or current sleep disorders.
- Subject must sign a written consent form.
Exclusion Criteria
- Recent history of night shift work or jet lag.
- Prior experience sleeping in a sleep lab environment.
- History of sleep disorders.
Data sourced from ClinicalTrials.gov (NCT00291187). 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.