Status:
TERMINATED
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared ag...
Eligibility Criteria
Inclusion
- Diagnosis of Primary Insomnia
- Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
- Patient is willing to avoid alcohol on PSG visits
- Patient will avoid napping during the course of the study
- Patient's bedtime is between 9pm and 1am
Exclusion
- History of substance abuse, bipolar disorder or psychotic disorder
- Difficulty sleeping due to other medical condition
- History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
- History of neoplastic malignancy within the last 5 years
- Positive alcohol breath test during the screening visits
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00420810
Start Date
September 1 2006
Last Update
January 14 2015
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