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

Condition(s) targeted: Primary Insomnia

Intervention: eszopiclone 1 mg (Drug); eszopiclone 2 mg (Drug); eszopiclone 3 mg (Drug); Placebo (Drug); zolpidem tartrate 10 mg (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Atsushi Kamijo, Study Director, Affiliation: New Product Development Department, Clinical Research Center

Overall contact:
Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: Latency to persistent sleep and sleep latency (co-primary measures).

Secondary outcome: Objective total sleep time, sleep efficiency and subjective evaluation by questionnaires

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese patients with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Patients will be randomly assigned to one of five treatment arms.

Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent.

2. Patients diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

- Sleep latency of more than or equal to 30 minutes for more than or equal to 3

days a week

- Total sleep time of less than or equal to 390 minutes for more than or equal to

3 days a week

3. Patients who meet both of the following based on polysomnogram (PSG) in observation period:

- Objective sleep latency of more than or equal to 20 minutes for 2 consecutive

PSG days

- Objective total sleep time of less than or equal to 420 minutes for 2

consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

1. Patients with comorbid primary sleep disorders (e. g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.

2. Patients with insomnia caused by pharmacological actions (drug-induced insomnia).

3. Patients with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).

4. Patients with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.

5. Patients with organic mental disorder.

Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

Akita, Japan; Recruiting

Fukuoka, Japan; Recruiting

Gifu, Japan; Recruiting

Kochi, Japan; Recruiting

Kumamoto, Japan; Recruiting

Osaka, Japan; Recruiting

Toyohashi, Aichi, Japan; Recruiting

Kurume, Fukuoka, Japan; Recruiting

Kitakyushu, Fukuoka, Japan; Recruiting

Sapporo, Hokkaido, Japan; Recruiting

Otaru, Hokkaido, Japan; Recruiting

Kawasaki, Kanagawa, Japan; Recruiting

Urazoe, Okinawa, Japan; Recruiting

Sakai, Osaka, Japan; Recruiting

Kodaira, Tokyo, Japan; Recruiting

Shibuya, Tokyo, Japan; Recruiting

Starting date: September 2008
Last updated: August 26, 2009