VEC-162 Study in Adult Patients With Primary Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: VEC-162 20 mg
* Drug: Placebo
* Drug: VEC-162 50 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VEC-162 20 mg<br>VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks | Drug: VEC-162 20 mg<br>* 20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks<br>|
| Experimental: VEC-162 50 mg<br>VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks | Drug: VEC-162 50 mg<br>* 50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsules PO daily five weeks | Drug: Placebo<br>* Placebo capsules, PO daily for five weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change From Baseline - Latency to Persistent Sleep (LPS) | Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8. | Baseline, Night 1, and Night 8 measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8. | Baseline, Night 1, and Night 8 measurements for WASO and TST |