A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia

Completed · Phase 4 · Has a placebo group

Conditions studied: Insomnia

In brief

To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.

Key facts

Study ID

NCT00386334

Run by

Sumitomo Pharma America, Inc.

People needed

388

Starts

2006-10-01

Expected to finish

2008-02-01

Last updated by the study team

2016-03-14

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.

You may not qualify if…

• Subject has recent history of known clinically significant abnormal laboratory findings.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Irvine, California, United States
• Study site — La Mesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Atlanta, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gables, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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