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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00770692
First received: October 9, 2008
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: Eszopiclone 1 mg- Elderly
Drug: Eszopiclone 2 mg- Elderly
Drug: Eszopiclone 3 mg- Non-elderly
Drug: Eszopiclone 2 mg- Non-elderly
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Up to 25 weeks (24 weeks treatment period & 1 week follow-up) ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Mean Change From Baseline In Sleep Latency [ Time Frame: Baseline (screening period) and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).

  • Mean Change From Baseline in Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline (screening period) and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).

  • Mean Change From Baseline in Total Sleep Time [ Time Frame: Baseline (screening period) and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).

  • Mean Change From Baseline in Total Number of Awakenings [ Time Frame: Baseline (screening period) and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).


Enrollment: 369
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eszopiclone 1 mg- Elderly Drug: 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.

Other Name: SEP-190
Experimental: Eszopiclone 2 mg- Elderly 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.

Other Name: SEP-190
Experimental: Eszopiclone 2 mg- Non-elderly 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.

Other Name: SEP-190
Experimental: Eszopiclone 3 mg- Non-elderly 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.

Other Name: SEP-190

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.

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770692

Locations
Japan
Nagoya, Aichi, Japan
Iizuka, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Onga, Fukuoka, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Itami, Hyogo, Japan
Yokohama, Kanagawa, Japan
Yokoyama, Kanagawa, Japan
Kashiba, Nara, Japan
Urazoe, Okinawa, Japan
Ibaragi, Osaka, Japan
Kishiwada, 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
Ota-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Sagamihara, Yokohama, Japan
Akita, Japan
Fukuoka, Japan
Kochi, Japan
Kumamoto, Japan
Kyoto, Japan
Osaka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Atsushi Kamijo New Product Development Department, Clinical Research Center
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00770692     History of Changes
Other Study ID Numbers: 190-150
Study First Received: October 9, 2008
Results First Received: October 24, 2012
Last Updated: October 24, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
insomnia
primary insomnia
insomnia associated with psychiatric or physical disorder(s)

Additional relevant MeSH terms:
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014