A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.

Official Title
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PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Placebo
* Drug: PD 0200390
* Drug: PD 0200390
* Drug: PD 0200390


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 month history of primary insomnia Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening) Exclusion Criteria: Any history of psychiatric diagnosis History or presence of any breathing related sleep disorder History or presence of any medical or neurological condition that could interfere with sleep Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.<br>|
| Experimental: PD 0200390, 5 mg<br> | Drug: PD 0200390<br>* Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.<br>|
| Experimental: PD 0200390, 15 mg<br> | Drug: PD 0200390<br>* Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.<br>|
| Experimental: PD 0200390, 30 mg<br> | Drug: PD 0200390<br>* Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake After Sleep Onset (WASO) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ) |  | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | 
| Latency to persistent sleep (LPS) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Latency to REM Sleep as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Sleep efficiency (SE) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Number of awakenings after sleep onset (NAASO) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Total wake time (TWT) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness |  | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | 
| Number of arousals as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Total sleep time (TST) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Next day performance sa determined by Digit Symbol Substitution Test (DSST) |  | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | 
| Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ) |  | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | 
| Wake time during sleep (WTDS) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Wake time after sleep (WTAS) as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment |  | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 | 
| Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D) |  | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep