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

Condition(s) targeted: Insomnia

Intervention: eszopiclone (Drug); eszopiclone (Drug); eszopiclone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Atsushi Kamijo, Study Director, Affiliation: New Product Development Department, Clinical Research Center

Overall contact:
Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

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.

Official title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

Study design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Adverse events.

Secondary outcome:

Adverse drug reactions, blood pressure, pulse rate, laboratory evaluations, electrocardiogram (ECG) measurements, questionnaire of drug dependence.

Sleep diary questionnaire

Sleep questionnaire, Pittsburgh sleep quality index Japanese version (PSQI), Short Form-36 Health Survey version 2-Japanese version (SF-36).

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.

Minimum age: 20 Years. Maximum age: 84 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

1. Patients who submit written informed consent for study entry.

2. Patients aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.

3. 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).

4. 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

5. 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:

1. 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

2. Patients with pharmacologically induced insomnia (drug-induced insomnia).

3. 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.

4. Patients with symptoms significantly disturb sleep such as pain, fever, diarrhea, frequent micturition, and cough.

5. Patients with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.

6. Patients with organic mental disorder.

Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

*, Akita *, Japan; Recruiting
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*, Sagamihara, Yokohama *, Japan; Recruiting
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Starting date: October 2008
Last updated: June 4, 2010