Status:
COMPLETED
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
Lead Sponsor:
Arena Pharmaceuticals
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will b...
Eligibility Criteria
Inclusion
- Men and women, ages 18 to 65 years
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
- 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
- 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 :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT00664664
Start Date
April 1 2008
End Date
November 1 2008
Last Update
December 24 2020
Active Locations (1)
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1
Arena Pharmaceuticals, Inc
San Diego, California, United States, 92121