Phase 3
Completed N=322
VEC-162 Study in Adult Patients With Primary Insomnia
Source: ClinicalTrials.gov NCT00548340 ↗Enrolled (actual)
322
Serious AEs
0.6%
Results posted
Oct 2014
Primary outcomePrimary: Average Change From Baseline - Latency to Persistent Sleep (LPS) — 45.0; 46.4; 28.3 minutes
Summary
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline - Latency to Persistent Sleep (LPS) |
49.4; 45.1; 33.9 | — |
| SECONDARY Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) |
17.7; 10.2; 20.3; 60.3; 48.6; 47.4 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
- Habitual bedtime between 9: 00 pm and 1:00 am.
- No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
- Patients must sign a written consent form.
Exclusion Criteria
- History of drug or alcohol abuse as defined in DSM-IV.
- History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
- History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
- Recent history of shift work or jet lag.
Data sourced from ClinicalTrials.gov (NCT00548340). 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.