Effects of Ramelteon on Driving Ability

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319215
• Other study ID #: 05/316
• Secondary ID: Studynumber:TAK-
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2006
• Last updated: April 24, 2007
• Start date: March 2006
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Ramelteon 8 mg

• Zopiclone 7.5 mg

Locations

Country	Name	City	State
Netherlands	Utrecht Institute for Pharmaceutical Sciences	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences	Takeda

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
Primary	Standard Deviation of Speed (SDS)
Secondary	Mean Speed (MS)
Secondary	Mean Lateral Position (MLP)
Secondary	Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
Secondary	Sternberg memory scanning test: reaction time and % errors
Secondary	Tracking task: RMS (tracking error)
Secondary	Divided attention test: RMS,reaction time and % errors
Secondary	DSST: number of copied symbols