A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Study Overview
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Brief Summary
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The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Official Title
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PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Conditions
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Primary Insomnia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 month history of Primary Insomnia (DSM-IV criteria) Self report sleep criteria for at least 3 nights per week in past month; sWASO (subjective wake after sleep onset) equal or greater than 60 mins sLSO (subjective latency to sleep onset) equal or greater than 45 minutes TST less than or equal to 6.5 hrs Maintain normal daytime-awake, nighttime-sleep schedule PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights TST between 3 to 7 hrs on 2 PSG screening nights Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights Exclusion Criteria: Comorbid psychiatric disease or disorders History or presence of breathing-related disorders Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening History or presence of medical or neurological condition interfering with sleep Current use of know psychotropic effect medications Excessive caffeine use Use of alcohol as a sleep aid or more than 2 standard drinks/day

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15 mg<br> | Drug: PD 0200390<br>* oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.<br>|
| Experimental: 30 mg<br> | Drug: PD 0200390<br>* oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.<br>|
| Experimental: 5 mg<br> | Drug: PD 0200390<br>* oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.<br>|
| Experimental: 60 mg<br> | Drug: PD 0200390<br>* oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire. |  | weekly | 
| Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ. |  | weekly | 
| PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT) |  | weekly | 
| Latency to persistent sleep (LPS) as determined by Polysomnography |  | weekly |