Status:
COMPLETED
Efficacy Study of EVT 201 to Treat Insomnia
Lead Sponsor:
Evotec Neurosciences GmbH
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
Brief Summary
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 contributi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00380003
Start Date
September 1 2006
End Date
April 1 2007
Last Update
January 30 2008
Active Locations (5)
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1
St Petersburg Sleep Disorders Center
St. Petersburg, Florida, United States, 33707
2
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States, 30342
3
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
4
St. Luke's Hospital
Chesterfield (St Louis), Missouri, United States, 63017