Effects of Ramelteon on Driving Ability

April 24, 2007 updated by: Utrecht Institute for Pharmaceutical Sciences

A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584CA
        • Utrecht Institute for Pharmaceutical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is male or female, 21 - 55 years of age, inclusive
  2. The subject is capable of understanding and complying with the protocol requirements.
  3. The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
  4. The subject, if female, is non-pregnant and non-lactating.
  5. Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
  6. An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.

Exclusion Criteria:

  1. The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
  2. The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.

5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
Standard Deviation of Speed (SDS)

Secondary Outcome Measures

Outcome Measure
Mean Speed (MS)
Mean Lateral Position (MLP)
Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
Sternberg memory scanning test: reaction time and % errors
Tracking task: RMS (tracking error)
Divided attention test: RMS,reaction time and % errors
DSST: number of copied symbols

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utrecht Institute for Pharmaceutical Sciences

Collaborators

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

April 26, 2006

First Submitted That Met QC Criteria

April 26, 2006

First Posted (ESTIMATE)

April 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2007

Last Update Submitted That Met QC Criteria

April 24, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/316
  • Studynumber:TAK-375/EC103
  • EudraCT Number 2005-005553-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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