A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

Study Overview
=================
Brief Summary
-----------------
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.

Official Title
-----------------
PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep

Conditions
-----------------
Nonrestorative Sleep

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins. Exclusion Criteria: MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening BMI = or > 32 kg/m2 History or presence of breathing related disorders PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15 mg<br> | Drug: PD 0200390<br>* oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.<br>|
| Experimental: 25 mg<br> | Drug: PD 0200390<br>* oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.<br>|
| Experimental: 35 mg<br> | Drug: PD 0200390<br>* oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.<br>|
| Experimental: 5 mg<br> | Drug: PD 0200390<br>* oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.<br>|
| Experimental: 50 mg<br> | Drug: PD 0200390<br>* oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral placebo daily dose, 3 capsules per dose during a six week treatment period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly) |  | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire |  | Weeky | 
| Total score of the Daily Restorative Sleep Questionnaire |  | Daily | 
| Total score of the Multidimensional Assessment of Fatigue (MAF) |  | Weekly | 
| Total score of the Sheehan Disability Scale to measure functional impairment |  | Weekly | 
| Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute) |  | Weekly | 
| Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF) |  | Weekly | 
| Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity. |  | Weekly | 
| Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician. |  | Weekly | 
| Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC). |  | Weekly |