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CompletedNCT00319215Updated Apr 25, 2007

Effects of Ramelteon on Driving Ability

A Phase 1 interventional study of Ramelteon 8 mg and Zopiclone 7.5 mg in Insomnia, sponsored by Utrecht Institute for Pharmaceutical Sciences. Completed at 1 site in Netherlands. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-25.

Sponsored by Utrecht Institute for Pharmaceutical Sciences · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia

Keywords

  • ramelteon
  • zopiclone
  • driving
  • memory
  • balance
  • psychomotor
03

In context

Sleep Initiation and Maintenance Disorders

1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Utrecht Institute for Pharmaceutical Sciences is the lead sponsor of 12 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
30 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.

  2. Standard Deviation of Speed (SDS)

Secondary outcomes

  1. Mean Speed (MS)

  2. Mean Lateral Position (MLP)

  3. Word Learning test:Immediate recall, Delayed Recall, Recognition time & score

  4. Sternberg memory scanning test: reaction time and % errors

  5. Tracking task: RMS (tracking error)

  6. Divided attention test: RMS,reaction time and % errors

  7. DSST: number of copied symbols

07

Study locations

1 site
  • Utrecht Institute for Pharmaceutical Sciences
    Utrecht, Utrecht 3584CA, Netherlands
08

References and documents

Publications

  • Mets MA, de Vries JM, de Senerpont Domis LM, Volkerts ER, Olivier B, Verster JC. Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep. 2011 Oct 1;34(10):1327-34. doi: 10.5665/SLEEP.1272. PubMed 21966064 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00319215
Lead sponsor
Utrecht Institute for Pharmaceutical Sciences
Collaborators
Takeda
First posted
Apr 27, 2006
Start date
Mar 2006
Completion
Jul 2006
Last update
Apr 25, 2007

Study contacts

Joris Verster, PhD
principal investigator · Utrecht Institute for Pharmaceutical Sciences
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Ramelteon · Zopiclone

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