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History of Changes for Study: NCT00770510
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
Latest version (submitted December 28, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2008 None (earliest Version on record)
2 December 5, 2008 Study Status and Study Description
3 December 8, 2008 Study Status
4 August 10, 2009 Outcome Measures, Sponsor/Collaborators, Study Status, Contacts/Locations and Arms and Interventions
5 August 26, 2009 Sponsor/Collaborators and Study Status
6 February 11, 2010 Contacts/Locations, Sponsor/Collaborators and Study Status
7 June 4, 2010 Study Status
8 November 16, 2010 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Sponsor/Collaborators, Study Design and Conditions
9 December 28, 2012 Outcome Measures, Study Status, Arms and Interventions, Sponsor/Collaborators, Study Description, Results, Eligibility, Study Design, Oversight and Study Identification
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Study NCT00770510
Submitted Date:  October 9, 2008 (v1)
Open or close this module Study Identification
Unique Protocol ID: 190-126
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2008
Overall Status: Recruiting
Study Start: September 2008
Primary Completion: May 2010 [Anticipated]
Study Completion:
First Submitted: October 9, 2008
First Submitted that
Met QC Criteria:		 October 9, 2008
First Posted: October 10, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:		 October 9, 2008
Last Update Posted: October 10, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Eisai Limited
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study is to investigate and evaluate the efficacy of eszopiclone in Japanese patients with primary insomnia.
Detailed Description:

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.

(Note: This clinical trial was quality controlled by itself, since no protocol was available to Eisai Medical Research Inc.)
Open or close this module Conditions
Conditions: Primary Insomnia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Crossover Assignment
Number of Arms: 5
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 70 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1 Drug: eszopiclone 1 mg
1 mg tablet, taken orally at bed time for 2 consecutive nights.
Other Names:
  • SEP-190
Experimental: 2 Drug: eszopiclone 2 mg
2 mg tablet, taken orally at bed time for 2 consecutive nights
Other Names:
  • SEP-190
Experimental: 3 Drug: eszopiclone 3 mg
3 mg tablet, taken orally at bed time for 2 consecutive nights.
Other Names:
  • SEP-190
Placebo Comparator: 4 Drug: Placebo
Placebo tablet, taken orally at bed time for 2 consecutive nights.
Active Comparator: 5 Drug: zolpidem tartrate 10 mg
zolpidem tartrate, 10 mg tablet, taken orally at bed time for 2 consecutive nights.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Latency to persistent sleep and sleep latency (co-primary measures)
[ Time Frame: 2 consecutive nights of each term; number of terms = 5. ]
Secondary Outcome Measures:
1. Objective total sleep time, sleep efficiency and subjective evaluation by questionnaires
[ Time Frame: 2 consecutive nights of each term; number of terms = 5. ]
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Customer Information Services Department. CRC and QA
Email: _ML_CLNCL@hhc.eisai.co.jp
Study Officials: Atsushi Kamijo
Study Director
New Product Development Department, Clinical Research Center
Locations: Japan
[Recruiting]
Akita, Japan
[Recruiting]
Fukuoka, Japan
[Recruiting]
Kochi, Japan
[Recruiting]
Kumamoto, Japan
[Recruiting]
Osaka, Japan
Japan, Aichi
[Recruiting]
Toyohashi, Aichi, Japan
Japan, Fukuoka
[Recruiting]
Kitakyushu, Fukuoka, Japan
[Recruiting]
Kurume, Fukuoka, Japan
Japan, Hokkaido
[Recruiting]
Otaru, Hokkaido, Japan
[Recruiting]
Sapporo, Hokkaido, Japan
Japan, Kanagawa
[Recruiting]
Kawasaki, Kanagawa, Japan
Japan, Okinawa
[Recruiting]
Urazoe, Okinawa, Japan
Japan, Osaka
[Recruiting]
Sakai, Osaka, Japan
Japan, Tokyo
[Recruiting]
Kodaira, Tokyo, Japan
[Recruiting]
Shibuya, Tokyo, Japan
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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