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

Sponsored by:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00386334

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: Eszopiclone	Phase IV

Drug Information available for: Eszopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

The primary efficacy endpoint will be the change from baseline in subject reported TST averaged over the 12-week double-blind study period. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The change 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	430
Study Start Date:	October 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Eszopiclone Placebo; Eszopiclone 2 mg tablets
2: Active Comparator Eszopiclone 2 mg tablets	Drug: Eszopiclone Placebo; Eszopiclone 2 mg tablets

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.

Eligibility

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386334

Show 81 Study Locations

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

Medical Director, CNS

Sepracor, Inc.

More Information

Lunesta Patient Instructions for Use This link exits the ClinicalTrials.gov site

Responsible Party:	Sepracor Inc. ( Executive Medical Director, Clinical Research )
Study ID Numbers:	190-904
Study First Received:	October 9, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00386334
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

insomnia
chronic
primary

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009