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

Phase 2

Withdrawn

• Conditions: Insomnia
• Interventions: Drug: Placebo; Drug: PD 0200390

• Registration Number: NCT00748592
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Study Start: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12
• Primary Completion: 2009-06
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PD 0200390, 5 mg	PD 0200390	-
PD 0200390, 15 mg	PD 0200390	-
PD 0200390, 30 mg	PD 0200390	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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