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

NCT ID: NCT00770510

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-05-31

Brief Summary

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

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 participants 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. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eszopiclone 1 mg

Group Type: EXPERIMENTAL

Eszopiclone 1 mg

Intervention Type: DRUG

Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Eszopiclone 2 mg

Group Type: EXPERIMENTAL

Eszopiclone 2 mg

Intervention Type: DRUG

Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Eszopiclone 3 mg

Group Type: EXPERIMENTAL

Eszopiclone 3 mg

Intervention Type: DRUG

Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Zolpidem Tartrate 10 mg

Group Type: ACTIVE_COMPARATOR

Zolpidem Tartrate 10 mg

Intervention Type: DRUG

Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Interventions

Eszopiclone 1 mg

Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Intervention Type: DRUG

Eszopiclone 2 mg

Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Intervention Type: DRUG

Eszopiclone 3 mg

Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Intervention Type: DRUG

Placebo

Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Intervention Type: DRUG

Zolpidem Tartrate 10 mg

Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Intervention Type: DRUG

Other Intervention Names

SEP-190; SEP-190; SEP-190

Eligibility Criteria

Inclusion Criteria

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

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

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

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

5. Participants with organic mental disorder.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atsushi Kamijo

Role: STUDY_DIRECTOR

New Product Development Department, Clinical Research Center

Locations

Toyohashi, Aichi-ken, Japan

Akita, Akita, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Gifu, Gifu, Japan

Hiroshima, Hiroshima, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kagoshima, Kagoshima-ken, Japan

Kawasaki, Kanagawa, Japan

Kochi, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Urazoe, Okinawa, Japan

Osaka, Osaka, Japan

Sakai, Osaka, Japan

Kodaira, Tokyo, Japan

Setagaya City, Tokyo, Japan

Shibuya City, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 23063301 (View on PubMed)

Other Identifiers

190-126

Identifier Type: -

Identifier Source: org_study_id