This Phase II trial, sponsored by Pfizer, is recruiting hundreds of adults ages 18 through 64 with nonrestorative sleep at (most of) 61 study locations in the U.S. and Canada. The trial will test the relative effect of different doses of a drug identified as PD 0200390 vs. a placebo (fake) dose.
Eligible patients will be those who with certain frequency awaken less than 45 minutes after sleep onset; awake in the morning unrestored or unrefreshed, with impairment in important area(s) of functioning during the day. Subjects should not have breathing disorders such as sleep apnea; or restless legs syndrome.
Factors tracked weekly by a variety of measures include restorative value of sleep assessed in morning, early morning behavior, and daytime fatigue. Secondarily the study will assess mood, function, work productivity, overall health status and more.
For more information on the trial, inclusion and exclusion criteria, and locations of the 61 recruiting sites, visit the ClinicalTrials.gov listing for “A Double-Blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep.”
For questions and to enquire about participating, call the central Pfizer ClinicalTrials.gov Call Center (1-800-718-1021) and refer to study NCT00655369.