A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Official Title: “PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia”

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Intervention(s) in this Clinical Trial

• Drug: PD 0200390
  • oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• Drug: PD 0200390
  • oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• Drug: PD 0200390
  • oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• Drug: PD 0200390
  • oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• Other: Placebo
  • oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 15 mg
• Experimental: 30 mg
• Experimental: 5 mg
• Experimental: 60 mg
• Placebo Comparator: Placebo

Primary Measures

• Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
  • Time Frame: weekly
    Safety Issue?: No

Secondary Measures

• Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.
  • Time Frame: weekly
    Safety Issue?: No
• Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.
  • Time Frame: weekly
    Safety Issue?: No
• PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)
  • Time Frame: weekly
    Safety Issue?: No
• Latency to persistent sleep (LPS) as determined by Polysomnography
  • Time Frame: weekly
    Safety Issue?: No

Inclusion Criteria:

• 3 month history of Primary Insomnia (DSM-IV criteria)
• Self report sleep criteria for at least 3 nights per week in past month;
• sWASO (subjective wake after sleep onset) equal or greater than 60 mins
• sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
• TST less than or equal to 6.5 hrs
• Maintain normal daytime-awake, nighttime-sleep schedule
• PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
• TST between 3 to 7 hrs on 2 PSG screening nights
• Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights

Exclusion Criteria:

• Comorbid psychiatric disease or disorders
• History or presence of breathing-related disorders
• Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
• History or presence of medical or neurological condition interfering with sleep
• Current use of know psychotropic effect medications
• Excessive caffeine use
• Use of alcohol as a sleep aid or more than 2 standard drinks/day

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00551148

Study ID Number: A4251068

ClinicalTrials.gov Identifier: NCT00551148

Health Authority: United States: Food and Drug Administration

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