Efficacy Study of EVT 201 to Treat Insomnia
Completed · Phase 2
Conditions studied: Sleep Initiation and Maintenance Disorders
In brief
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).
Key facts
- Study ID
- NCT00380003
- Run by
- Evotec Neurosciences GmbH
- People needed
- 66
- Starts
- 2006-09-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2008-01-30
Who can join
Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- must have a diagnosis of primary insomnia
- over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
- must be willing and able to complete a sleep diary and questionnaires
You may not qualify if…
- must not have a clinically significant or unstable medical condition that may interfere with sleep
- must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
- must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
- must not intentionally nap 3 (or more) times per week
- must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
Where it is running
- 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
- Tri-State Sleep Disorders Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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