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

Sponsored by:	Eisai Limited
Information provided by:	Eisai Medical Research 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

Drug Information available for: Eszopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Adverse events [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse drug reactions, questionnaire of drug dependence, Pittsburgh Sleet Quality Index, Short Form (PSQI), SF-36. [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: eszopiclone For elderly patients: 1 mg tablet, each night for 6 months.
2: Experimental	Drug: eszopiclone For elderly patients: 2 mg tablet, each night for 6 months.
3: Experimental	Drug: eszopiclone For non-elderly patients: 2 mg tablet, each night for 6 months.
4: Placebo Comparator	Drug: Placebo For non-elderly patients: placebo comparator: 3 mg tablet, 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 5.0.0:
- 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, 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

Contacts

Contact: Customer Information Services Department. CRC and QA

_ML_CLNCL@hhc.eisai.co.jp

Show 30 Study Locations

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:

Atsushi Kamijo

New Product Development Department, Clinical Research Center

More Information

Responsible Party:	Eisai Company Limited ( Customer Information Services Department. CRC and QA )
Study ID Numbers:	190-150
Study First Received:	October 9, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00770692
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Medical Research Inc.:

insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009