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Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00368056
First received: August 23, 2006
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.


Condition Intervention Phase
Primary Insomnia
Drug: Eszopiclone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • next day performance in a standardised test of car driving [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compensatory Tracking Task (CTT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Rapid Visual Information Processing (RVIP) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Sternberg's Short-term Memory Scanning task (STM) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Critical Flicker Fusion (CFF) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Test (DSST) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Choice Reaction Time (CRT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
  • Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • S-Zopiclone
  • Lunesta
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
Placebo tablet

Detailed Description:

The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 55 years inclusive
  • In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
  • Diagnostic and statistical manual of mental disorders, defined primary insomnia
  • A body mass index greater than or equal to 18 and less than or equal to 30
  • Registered with a general practitioner (GP)
  • Hold a full current driving licence for at least one year, and be regular car drivers

Exclusion Criteria

  • The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
  • Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
  • Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
  • Any subject with known hypersensitivity to any of the study treatments
  • A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
  • Pregnant or lactating females, and females of child bearing potential not using effective contraception
  • Patients who habitually smoke more than 5 cigarettes per day
  • Caffeine consumption of more than 5 cups or glasses per day
  • History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
  • Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368056

Locations
United Kingdom
HPRU Medical Research Centre, University of Surrey
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00368056     History of Changes
Other Study ID Numbers: 190-060
Study First Received: August 23, 2006
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014