Safety and Efficacy Study of APD125 in Patient With Insomnia

Completed · Phase 2

Conditions studied: Insomnia

In brief

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

Key facts

Study ID

NCT00452179

Run by

Arena Pharmaceuticals

People needed

173

Starts

2007-02-01

Expected to finish

2007-06-01

Last updated by the study team

2007-09-10

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

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