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

NCT00770692 | Completed Phase 3 Results

• 1 other identifier: 190-150
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 34

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.

Conditions

Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100. An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.

  Up to 25 weeks (24 weeks treatment period & 1 week follow-up)

Secondary Outcomes (4)

• Mean Change From Baseline In Sleep Latency

  Baseline (screening period) and 4 weeks of treatment

• Mean Change From Baseline in Wake Time After Sleep Onset (WASO)

  Baseline (screening period) and 4 weeks of treatment

• Mean Change From Baseline in Total Sleep Time

  Baseline (screening period) and 4 weeks of treatment

• Mean Change From Baseline in Total Number of Awakenings

  Baseline (screening period) and 4 weeks of treatment

Study Arms (4)

Eszopiclone 1 mg- Elderly

EXPERIMENTAL

Drug: Eszopiclone 1 mg- Elderly

Eszopiclone 2 mg- Elderly

EXPERIMENTAL

Drug: Eszopiclone 2 mg- Elderly

Eszopiclone 2 mg- Non-elderly

EXPERIMENTAL

Drug: Eszopiclone 2 mg- Non-elderly

Eszopiclone 3 mg- Non-elderly

EXPERIMENTAL

Drug: Eszopiclone 3 mg- Non-elderly

Interventions

Eszopiclone 1 mg- Elderly 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.

Also known as: SEP-190

Eszopiclone 1 mg- Elderly

Eszopiclone 2 mg- Elderly 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.

Also known as: SEP-190

Eszopiclone 2 mg- Elderly

Eszopiclone 3 mg- Non-elderly 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.

Also known as: SEP-190

Eszopiclone 3 mg- Non-elderly

Eszopiclone 2 mg- Non-elderly 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.

Also known as: SEP-190

Eszopiclone 2 mg- Non-elderly

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who submit written informed consent for study entry.
• Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
• 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).
• 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
• 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

You may not qualify if:

• 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
• Participants with pharmacologically induced insomnia (drug-induced insomnia).
• 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.
• Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
• Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
• Participants with organic mental disorder.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (34)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

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Akita, Akita, Japan

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Fukuoka, Fukuoka, Japan

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Iizuka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Koga, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Itami, Hyōgo, Japan

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Yokohama, Kanagawa, Japan

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Yokoyama, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Kashiba, Nara, Japan

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Urazoe, Okinawa, Japan

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Ibaraki, Osaka, Japan

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Kishiwada, Osaka, Japan

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Osaka, Osaka, Japan

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Fujimi, Saitama, Japan

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Kusatsu, Shiga, Japan

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Arakawa-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Edogawa-ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Musashino, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Sagamihara, Yokohama, Japan

Location

Related Publications (1)

• 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.

  PMID: 22731653 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone; Aging

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Growth and Development; Physiological Phenomena

Results Point of Contact

• Title: Atsushi Kamijo, Study Director
• Organization: Eisai Co., Ltd.

a-kamijo@hhc.eisai.co.jp

+81-3-3817-5245

Study Officials

• Atsushi Kamijo

  New Product Development Department, Clinical Research Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 22, 2012
• Results First Posted: November 22, 2012

Record last verified: 2012-10

Locations

JP (34)