Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.

Official Title
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: EVT 201


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary insomnia according to DSM-IV Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period Willing and able to complete a sleep diary and questionnaires Exclusion Criteria: Clinically significant or unstable medical condition that may interfere with sleep Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening History of substance abuse Disorders that interfere with drug pharmacokinetics History of cancer, except basal cell carcinoma Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip) Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer Consuming ≥ 350 mg per day of xanthine-containing food or beverages Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours) Body mass index > 34 kg/m2; Performing night work or rotating shift work during the past month Traveling across > 3 time zones in the past 2 weeks Participation in another trial of an investigational product or device within the previous 30 days Known allergy or sensitivity to benzodiazepines

Ages Eligible for Study
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Minimum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: EVT 201|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Multiple Sleep Latency Test at Day 8 |  |  | 
| Mean Psychomotor Vigilance Task at Day 8 |  |  | 
| Mean Karolinska Sleepiness Scale at Day 8 |  |  | 
| Mean Rey Auditory Verbal Learning Test at Day 8 |  |  | 
| Mean Profile of Mood State at Day 8 |  |  | 
| Polysomnography derived variables averaged over nights 1, 6 and 7 |  |  | 
| Patient reported evaluations of sleep quality and quantity over nights 1 to 7 |  |  | 
| Benzodiazepine withdrawal questionnaire at baseline and follow-up |  |  | 
| Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study |  |  |