Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 be required to maintain a daily sleep dairy for up to 3 weeks while on study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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