Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia

NCT01710631 | Completed Phase 3

• 1 other identifier: 190-049
• Study Type: interventional
• Target: 791
• Locations: 0 countries
• Sites: N/A

Brief Summary

A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.

Conditions

Primary Insomnia

Keywords

Sleep

Outcome Measures

Primary Outcomes (2)

• Average sleep latency over the last half of the double-blind study period ("last-three-month average" = mean of the monthly averages for months 4, 5, and 6)

  Months 4-6

• Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone

  12 Months

Secondary Outcomes (7)

• Subjective Total sleep time

  Months 4-6 average

• Subjective Sleep latency

  Months 1-3

• Number of awakenings

  Months 1-12

• Wake Time After Sleep Onset (WASO)

  Months 1-12

• Quality of Sleep

  Months 1-12

Study Arms (2)

eszopiclone 3 mg

EXPERIMENTAL

eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).

Drug: eszopiclone 3 mg

placebo

PLACEBO COMPARATOR

placebo tablet

Drug: placebo

Interventions

eszopiclone 3 mg DRUG

eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).

Also known as: lunesta

eszopiclone 3 mg

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for primary insomnia and reported sleeping no more than 6.5 hours per night and/or taking more than 30 minutes each night to fall asleep for at least one month prior to screening.
• Subject was between 21 and 64 years of age (inclusive) at screening. Both males and females were eligible to participate.
• Subject provided written informed consent indicating that the purpose of the study was understood. The subject was willing to adhere to the regimen and study procedures described in this protocol.
• Females of childbearing potential must have willingly signed "Women of Child-Bearing Potential Informed Consent" addendum. Females considered not of childbearing potential must have been surgically sterile or greater than one-year post-menopausal, defined as a complete cessation of menstruation for at least one year.
• Subject's physical examination, including a brief neurological examination, showed no clinically significant abnormal findings at screening.
• Subject had no known clinically significant abnormal laboratory findings at screening.
• Subject had no clinically significant Electrocardiography (ECG) abnormalities at screening.

You may not qualify if:

• Subject had any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
• Subject had a history of, or current malignancy except for non-melanomatous skin cancer.
• Subject had objective evidence of active thyroid disease at screening. Subjects on thyroid replacement therapy were included as long as dose had been stable for ≥ 3 months.
• Subject had a DSM-IV Axis I psychiatric diagnosis other than Sexual and Gender Identity Disorders, or Axis II Personality Disorders (but not schizotypal, schizoid, or borderline personality disorder). Other non-psychotic Axis I disorders except dementia and delirium were considered on a case-by-case basis.
• Subject had a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that was contained in the formulation, or had been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).
• Subject had difficulties in sleep initiation or maintenance associated with known sleep difficulties (e.g. sleep apnea, restless leg syndrome, (RLS) or periodic leg movement syndrome (PLMS)), or had any condition which had, or may, affect sleep (e.g., chronic pain, Benign prostatic hyperplasia (BPH), etc.).
• Subject had history of substance abuse in the past 10 years or substance dependence at any time; positive urine drug test at screening.
• Subject tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result.
• Subject was known to be seropositive for Human immunodeficiency virus (HIV).
• Female subjects who were pregnant, lactating or within 6 months post-partum.
• Subject had a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may have interfered with drug absorption, distribution, metabolism, or excretion.
• Subject had used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
• Subject self-reported consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
• Subject had taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or was anticipated to need any of these types of medications during double-blind treatment.
• Subject had participated in any investigational study within 30 days prior to screening.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Lunesta Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: February 1, 2001
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: October 22, 2012

Record last verified: 2012-10