A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/27/2013 |
| Start Date: | September 2012 |
| End Date: | June 2013 |
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
the treatment of excessive daytime sleepiness in adults with narcolepsy.
Inclusion Criteria:
- Diagnosis of narcolepsy
- Good general health
- Willing and able to comply with the study design and schedule and other
requirements
Exclusion Criteria:
- If female, pregnant or lactating
- Customary bedtime later than midnight
- History of significant medical condition, behavioral, or psychiatric disorder
(including suicidal ideation), or surgical history
- Any other clinically relevant medical, behavioral or psychiatric disorder other than
narcolepsy that is associated with excessive sleepiness
- History of significant cardiovascular disease
- Body mass index > 34
- Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day
- History of alcohol or drug abuse within the past 2 years
- Nicotine dependence that has an effect on sleep
We found this trial at
32
sites
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400 Redland Ct.
Owings Mills, Maryland 21136
Owings Mills, Maryland 21136
410-494-7921
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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