A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

Summary

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Timeline

Start

2008-09

Primary completion

2010-05

Completion

2010-05

Outcome

Met primary endpoint

release “In a Phase II/III study (Study 126) conducted in Japan in patients with primary insomnia, Lunesta was shown to statistically significantly improve Sleep Latency (SL)” eisai.com ↗

release “In addition, Lunesta was shown in Study 126 to cause a statistically significant (when measured against placebo) reduction in latency to persistent sleep (LPS)” eisai.com ↗

Publications

• Uchimura N, Kamijo A, Kuwahara H, Uchiyama M, Shimizu T, Chiba S, Inoue Y. A randomized placebo-controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia. Sleep Med. 2012 Dec;13(10):1247-53. doi: 10.1016/j.sleep.2012.08.015. Epub 2012 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	1 mg	Oral
Subject	Eszopiclone	Small molecule	2 mg	Oral
Subject	Eszopiclone	Small molecule	3 mg	Oral
Comparator	Zolpidem	Small molecule	10 mg	Oral

Indications