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

NCT ID: NCT00770692

Last Updated: 2012-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-05-31

Brief 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

Keywords

insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)

Study Design

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

Study Groups

Eszopiclone 1 mg- Elderly

Group Type: EXPERIMENTAL

Eszopiclone 1 mg- Elderly

Intervention Type: DRUG

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.

Eszopiclone 2 mg- Elderly

Group Type: EXPERIMENTAL

Eszopiclone 2 mg- Elderly

Intervention Type: DRUG

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.

Eszopiclone 2 mg- Non-elderly

Group Type: EXPERIMENTAL

Eszopiclone 2 mg- Non-elderly

Intervention Type: DRUG

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.

Eszopiclone 3 mg- Non-elderly

Group Type: EXPERIMENTAL

Eszopiclone 3 mg- Non-elderly

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

SEP-190; SEP-190; SEP-190; SEP-190

Eligibility Criteria

Inclusion Criteria

1. Participants who submit written informed consent for study entry.

2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.

3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).

4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:

• Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
• Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:

• Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
• Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

Exclusion Criteria

1. Participants with a present or history of the following disease specified in

Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:

• Risk of suicide
• (Mild) manic episode
• Post-traumatic stress disorder (PTSD)
• Alcohol dependence and abuse
• Drug (non-alcohol) dependence and abuse
• Anorexia nervosa
• Bulimia nervosa
• Anti-social personality disorder

2. Participants with pharmacologically induced insomnia (drug-induced insomnia).

3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.

4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.

5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.

6. Participants with organic mental disorder.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 84 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

Nagoya, Aichi-ken, Japan

Akita, Akita, Japan

Fukuoka, Fukuoka, Japan

Iizuka, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Koga, Fukuoka, Japan

Kurume, Fukuoka, Japan

Maebashi, Gunma, Japan

Sapporo, Hokkaido, Japan

Itami, Hyōgo, Japan

Yokohama, Kanagawa, Japan

Yokoyama, Kanagawa, Japan

Kochi, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Kashiba, Nara, Japan

Urazoe, Okinawa, Japan

Ibaraki, Osaka, Japan

Kishiwada, Osaka, Japan

Osaka, Osaka, Japan

Fujimi, Saitama, Japan

Kusatsu, Shiga, Japan

Arakawa-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Edogawa-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Koto-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Musashino, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Toshima-ku, Tokyo, Japan

Sagamihara, Yokohama, Japan

Countries

Japan

References

Uchimura N, Kamijo A, Takase T. Effects of eszopiclone on safety, subjective measures of efficacy, and quality of life in elderly and nonelderly Japanese patients with chronic insomnia, both with and without comorbid psychiatric disorders: a 24-week, randomized, double-blind study. Ann Gen Psychiatry. 2012 Jun 25;11(1):15. doi: 10.1186/1744-859X-11-15.

Reference Type: DERIVED

PMID: 22731653 (View on PubMed)

Other Identifiers

190-150

Identifier Type: -

Identifier Source: org_study_id