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

NCT00748592 | Withdrawn Phase 2

• 1 other identifier: A4251026
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep

Outcome Measures

Primary Outcomes (1)

• Wake After Sleep Onset (WASO) as determined by PSG assessment

  Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23

Secondary Outcomes (15)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PD 0200390, 5 mg

EXPERIMENTAL

Drug: PD 0200390

PD 0200390, 15 mg

EXPERIMENTAL

Drug: PD 0200390

PD 0200390, 30 mg

EXPERIMENTAL

Drug: PD 0200390

Interventions

Placebo DRUG

Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.

Placebo

PD 0200390 DRUG

Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.

PD 0200390, 5 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 12, 2009

Record last verified: 2009-02