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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Insomnia
• Intervention / Treatment: Drug: Placebo; Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Estimate): February 12, 2009
• Last Update Submitted That Met QC Criteria: February 11, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: A4251026