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

Sponsor:	Eisai Co., Ltd.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00770692

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 Drug: Placebo	Phase III

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:

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Calculate the number of incidents, number of cases and the rate of incidence of adverse events in each administered group with respect to non-elderly and elderly patients. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Sleep diary questionnaire: sleep latency in elderly and non-elderly patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Sleep diary questionnaire: total sleep hours in elderly and non-elderly patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Sleep diary questionnaire: nocturnal arousal hours in elderly and non-elderly patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Sleep diary questionnaire: number of nocturnal arousals in elderly and non-elderly patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	320
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: 1	Drug: eszopiclone For elderly patients: eszopiclone 1 mg tablet, taken orally each night for 6 months. Other Name: SEP-190
Experimental: 2	Drug: eszopiclone For elderly patients: eszopiclone 2 mg tablet, taken orally each night for 6 months. Other Name: SEP-190
Experimental: 3	Drug: eszopiclone For non-elderly patients: eszopiclone 2 mg tablet, taken orally each night for 6 months. Other Name: SEP-190
Placebo Comparator: 4	Drug: Placebo For non-elderly patients: placebo comparator 3 mg tablet, taken orally each night for 6 months; eszopiclone 3 mg tablet, each night for 6 months.

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:

Patients who submit written informed consent for study entry.
Patients aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
Patients 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).
Patients 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
Patients 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:

Patients 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
Patients with pharmacologically induced insomnia (drug-induced insomnia).
Patients with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
Patients with symptoms significantly disturb sleep such as pain, fever, diarrhea, frequent macturition, and cough.
Patients with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
Patients with organic mental disorder.

Contacts and Locations

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

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:	Atsushi Kamijo, New Product Development Department, Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00770692 History of Changes
Other Study ID Numbers:	190-150
Study First Received:	October 9, 2008
Last Updated:	November 29, 2010
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:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Eszopiclone

Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012