Status:
COMPLETED
Safety and Efficacy Study of APD125 in Patient With Insomnia
Lead Sponsor:
Arena Pharmaceuticals
Conditions:
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.
Eligibility Criteria
Inclusion
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
- PSQI \>/= to 5
- Qualifying screening PSG parameters
- Generally good health
Exclusion
- History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
- Any clinically significant medical condition, laboratory finding, or ECG finding
- Pregnant and/or lactating females
- History of substance abuse within 2 years or positive urine drug screen
- Positive Hepatitis B/C results or HIV markers
- Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) \> 10 as determined by screening PSG
- History of treatment with an investigational drug within the last month
- Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00452179
Start Date
February 1 2007
End Date
June 1 2007
Last Update
September 10 2007
Active Locations (1)
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1
San Diego, California, United States, 92121