The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
St Petersburg Sleep Disorders Center
St. Petersburg, Florida, United States
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
St. Luke's Hospital
Chesterfield (St Louis), Missouri, United States
Total Sleep Time
Wake after sleep onset
Latency to persistent sleep
Number of awakenings
Total wake time
Minutes of stages 1-4 and REM sleep
REM latency
Patient reported sleep variables
Residual sedation measures
Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.
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Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States