NCT00770692

A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)

A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

Detailed description

This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone 1 mg- Elderly	Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
DRUG	Eszopiclone 2 mg- Elderly	Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
DRUG	Eszopiclone 3 mg- Non-elderly	Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
DRUG	Eszopiclone 2 mg- Non-elderly	Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-10-10
• Last updated: 2012-11-22
• Results posted: 2012-11-22

Locations

34 sites across 1 country: Japan