Safety and Efficacy Study of APD125 in Patient With Insomnia

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

• Phase: Phase 2

Details

• Lead Sponsor: Arena Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 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

• 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