NCT01710631

Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia

A Randomized, Double-Blind, Placebo-Controlled and Open-Label Twelve Month Study of the Safety of (S)-Zopiclone in Adult Subjects With Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 791 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.

Detailed description

A six month, randomized, double-blind and six month open-label extension, multi-center, outpatient study to determine the safety of eszopiclone in the treatment of adult subjects with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an additional 6 months. Subjects were allowed to stay on study for up to 12 months.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	eszopiclone 3 mg	eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
DRUG	placebo	placebo

Timeline

• Start date: 2001-02-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2012-10-19
• Last updated: 2012-10-22