A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Study Overview
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Brief Summary
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To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Official Title
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PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Conditions
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Insomnia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 month history of primary insomnia; 18 to 64 years For the last 3 months-regularly awake unrefreshed and unrestored 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 an Axis 1 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: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: 15 mg PD 0200390<br> | Drug: PD 0200390<br>* Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days<br>|
| Experimental: 30 mg PD 0200390<br> | Drug: PD 0200390<br>* Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days<br>|
| Experimental: 45 mg PD 0200390<br> | Drug: PD 0200390<br>* Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days<br>|
| Experimental: 60 mg PD 0200390<br> | Drug: PD 0200390<br>* Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days<br>|
| Experimental: Placebo PD 0200390<br> | Drug: Placebo<br>* Matched oral placebo for weeks 2-7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia. |  | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. |  | Weekly | 
| To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia. |  | Weekly | 
| To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia. |  | Weekly | 
| To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia. |  | Weekly | 
| To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia. |  | Weekly |