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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Eszopiclone 1 mg- Elderly; Drug: Eszopiclone 2 mg- Elderly; Drug: Eszopiclone 2 mg- Non-elderly; Drug: Eszopiclone 3 mg- Non-elderly

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.

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan
  • Fukuoka, Japan
  • Kochi, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Osaka, Japan
  • Aichi
    • Nagoya, Aichi, Japan
  • Fukuoka
    • Iizuka, Fukuoka, Japan
    • Kitakyushu, Fukuoka, Japan
    • Kurume, Fukuoka, Japan
    • Onga, Fukuoka, Japan
  • Gunma
    • Maebashi, Gunma, Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan
  • Hyogo
    • Itami, Hyogo, Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan
    • Yokoyama, Kanagawa, Japan
  • Nara
    • Kashiba, Nara, Japan
  • Okinawa
    • Urazoe, Okinawa, Japan
  • Osaka
    • Ibaragi, Osaka, Japan
    • Kishiwada, Osaka, Japan
  • Saitama
    • Fujimi, Saitama, Japan
  • Shiga
    • Kusatsu, Shiga, Japan
  • Tokyo
    • 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
  • Yokohama
    • Sagamihara, Yokohama, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: SEP-190

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline In Sleep Latency	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).	Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)	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).	Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Total Sleep Time	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).	Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Total Number of Awakenings	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).	Baseline (screening period) and 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (ESTIMATE): October 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 22, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: 190-150