A Long-Term Safety & Efficacy Study of Eszopiclone in Elderly w. Primary Chronic Insomnia

Condition(s) targeted: Insomnia

Intervention: Eszopiclone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sepracor, Inc.

Overall contact:
Sepracor Central Contact, Phone: 866-503-6351

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy endpoint will be the change from baseline in subject reported TST averaged over the 12-week double-blind study period.

Secondary outcome: Thechange from baseline in subject reported Sleep Latency (SL) averaged over the 12-week double-blind period and subject reported Wake Time After Sleep Onset (WASO) averaged over the 12-week double-blind

Detailed description: A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks.

Minimum age: 65 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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

Sepracor Central Contact, Phone: 866-503-6351

Birmingham, Alabama 35226, United States; Recruiting

Glendale, Arizona 85306, United States; Recruiting

Tucson, Arizona 85712, United States; Recruiting

Chandler, Arizona 85225, United States; Active, not recruiting

Irvine, California 92618, United States; Recruiting

San Diego, California 92121, United States; Recruiting

La Mesa, California 91942, United States; Recruiting

Denver, Colorado 80212, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Delray Beach, Florida 33458, United States; Recruiting

Gables, Florida 33134, United States; Recruiting

Coral Springs, Florida 33065, United States; Recruiting

Pembroke Pines, Florida 33024, United States; Recruiting

Jupiter, Florida 33458, United States; Recruiting

Naples, Florida 34110, United States; Recruiting

Ft. Myers, Florida 33912, United States; Recruiting

Maitland, Florida 32751, United States; Recruiting

Sarasota, Florida 34238, United States; Recruiting

West Palm Beach, Florida 33407, United States; Recruiting

Clearwater, Florida 33765, United States; Recruiting

St. Petersburg, Florida 33707, United States; Recruiting

Pinellas Park, Florida 33781, United States; Active, not recruiting

Atlanta, Florida 30342, United States; Recruiting

Stockbridge, Georgia 30281, United States; Recruiting

Honolulu, Hawaii 96814, United States; Recruiting

Chicago, Illinois 60610, United States; Recruiting

Evansville, Indiana 47714, United States; Recruiting

Prairie Village, Kansas 66206, United States; Active, not recruiting

Crestview Hills, Kentucky 41017, United States; Recruiting

Baltimore, Maryland 21208, United States; Recruiting

Braintree, Massachusetts 02184, United States; Recruiting

Newton, Massachusetts 02459, United States; Recruiting

Florissant, Missouri 63031, United States; Recruiting

Hamilton, New Jersey 08690, United States; Recruiting

Rochester, New York 14609, United States; Recruiting

New York, New York 10023, United States; Recruiting

Brooklyn, New York 11235, United States; Recruiting

New York, New York 10021, United States; Recruiting

Mineola, New York 11501, United States; Recruiting

Cary, North Carolina 27540, United States; Recruiting

Durham, North Carolina 27710, United States; Recruiting

Cleveland, Ohio 44122, United States; Recruiting

Cincinnati, Ohio 45206, United States; Recruiting

Mogadore, Ohio 44260, United States; Recruiting

Oklahoma City, Oklahoma 73103, United States; Active, not recruiting

Oklahoma City, Oklahoma 73112, United States; Recruiting

Scotland, Pennsylvania 17254, United States; Active, not recruiting

Warwick, Rhode Island 02886, United States; Recruiting

Simpsonville, South Carolina 29681, United States; Recruiting

Anderson, South Carolina 29621, United States; Active, not recruiting

Houston, Texas 77024, United States; Recruiting

San Antonio, Texas 78205, United States; Active, not recruiting

San Antonio, Texas 78229, United States; Recruiting

San Antonio, Texas 78238, United States; Active, not recruiting

Wichita Falls, Texas 76309, United States; Recruiting

Dallas, Texas 75231, United States; Active, not recruiting

Starting date: October 2006
Ending date: October 2007
Last updated: June 26, 2007