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

Official Title: “A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia”

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

This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese patients 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. Patients will be randomly assigned to one of five treatment arms.

Intervention(s) in this Clinical Trial

• Drug: eszopiclone 1 mg
  • eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights
• Drug: eszopiclone 2 mg
  • eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights
• Drug: eszopiclone 3 mg
  • eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights
• Drug: Placebo
  • Placebo tablet, taken orally at bed time for 2 consecutive nights
• Drug: zolpidem tartrate 10 mg
  • zolpidem tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Placebo Comparator: 4
• Active Comparator: 5

Primary Measures

• Latency to persistent sleep and sleep latency (co-primary measures)
  • Time Frame: Every dosing visit
    Safety Issue?: No

Secondary Measures

• Objective total sleep time, sleep efficiency and subjective evaluation by questionnaires.
  • Time Frame: Every dosing visit
    Safety Issue?: No

Inclusion Criteria:

• 1. Patients aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent.
• 2. Patients 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. Patients 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. Patients 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. Patients with insomnia caused by pharmacological actions (drug-induced insomnia).
• 3. Patients with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
• 4. Patients with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
• 5. Patients with organic mental disorder.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eisai Co., Ltd. Industry

Overall Clinical Trial Officials and Contacts

Atsushi Kamijo Study Director New Product Development Department, Clinical Research Center  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00770510

Study ID Number: 190-126

ClinicalTrials.gov Identifier: NCT00770510

Health Authority: Japan: Ministry of Health, Labor and Welfare