CClinicalTrials.gg
CompletedNCT00368160Updated Feb 22, 2012

Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

A Phase 1 interventional study of Eszopiclone and Placebo in Insomnia, sponsored by Sumitomo Pharma America, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Sumitomo Pharma America, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.

Read the detailed description

The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers 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.

02

Conditions studied

  • Insomnia

Keywords

  • Next day driving
03

In context

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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

Exclusion Criteria

  • Clinically significant use of psychotropic medication in the last three months. For example, this would include the prolonged use of antidepressants, antipsychotics, or antihistamines, but would exclude the occasional use of cold or flu remedies (which often contain antihistamines and/ or opiates)
  • The use of any other medication in the last two weeks with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol
  • 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 (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
  • Volunteers 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    1

    eszopiclone 3 mg

    Drug: Eszopiclone

  • Placebo comparator
    2

    Placebo tablet

    Drug: Placebo

Interventions

  • DrugEszopiclone

    eszopiclone 3 mg

    Also known as: S-Zopiclone, Lunesta

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. next day performance in a standardised test of car driving

    Time frame: 9.5 hours post dose

Secondary outcomes

  1. Compensatory Tracking Task (CTT)

    Time frame: 9.5 hours post dose

  2. Rapid Visual Information Processing (RVIP)

    Time frame: 9.5 hours post dose

  3. Sternberg's Short-term Memory Scanning task (STM)

    Time frame: 9.5 hours post dose

  4. Critical Flicker Fusion (CFF)

    Time frame: 9.5 hours post dose

  5. Digit Symbol Substitution Test (DSST)

    Time frame: 9.5 hours post dose

  6. Choice Reaction Time (CRT)

    Time frame: 9.5 hours post dose

  7. Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales

    Time frame: 9.5 hours post dose

07

Study locations

1 site
  • HPRU Medical Research Centre
    Guildford, Surrey, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00368160
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Aug 24, 2006
Start date
Mar 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Feb 22, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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