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

Sponsor:	Eisai Co., Ltd.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00770510

Purpose

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

Condition	Intervention	Phase
Primary Insomnia	Drug: eszopiclone 1 mg Drug: eszopiclone 2 mg Drug: eszopiclone 3 mg Drug: Placebo Drug: zolpidem tartrate 10 mg	Phase II Phase III

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

Resource links provided by NLM:

Drug Information available for: Zolpidem Eszopiclone

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Latency to persistent sleep and sleep latency (co-primary measures) [ Time Frame: Every dosing visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective total sleep time, sleep efficiency and subjective evaluation by questionnaires. [ Time Frame: Every dosing visit ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	September 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: eszopiclone 1 mg eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights Other Name: SEP-190
Experimental: 2	Drug: eszopiclone 2 mg eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights Other Name: SEP-190
Experimental: 3	Drug: eszopiclone 3 mg eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights Other Name: 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

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.

Eligibility

Ages Eligible for Study:	21 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent.
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
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:

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.
Patients with insomnia caused by pharmacological actions (drug-induced insomnia).
Patients with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
Patients with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
Patients with organic mental disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770510

Locations

Japan

Toyohashi, Aichi, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kawasaki, Kanagawa, Japan

Urazoe, Okinawa, Japan

Sakai, Osaka, Japan

Kodaira, Tokyo, Japan

Setagaya, Tokyo, Japan

Shibuya, Tokyo, Japan

Akita, Japan

Fukuoka, Japan

Gifu, Japan

Hiroshima, Japan

Kagoshima, 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:	Atsushi Kamijo, New Product Development Department, Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00770510 History of Changes
Other Study ID Numbers:	190-126
Study First Received:	October 9, 2008
Last Updated:	November 16, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:

Primary insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012