NCT00319215

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

April 26, 2006

Last Update Submit

April 24, 2007

Conditions

Insomnia

Keywords

ramelteonzopiclonedrivingmemorybalancepsychomotor

Outcome Measures

Primary Outcomes (2)

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

  • Standard Deviation of Speed (SDS)

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Interventions

Ramelteon 8 mgDRUG
Zopiclone 7.5 mgDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The subject is male or female, 21 - 55 years of age, inclusive
  • The subject is capable of understanding and complying with the protocol requirements.
  • The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
  • The subject, if female, is non-pregnant and non-lactating.
  • 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.
  • 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.

You may not qualify if:

  • The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht Institute for Pharmaceutical Sciences

Utrecht, Utrecht, 3584CA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21966064DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteonzopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Joris Verster, PhD

    Utrecht Institute for Pharmaceutical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

March 1, 2006

Study Completion

July 1, 2006

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

NL(1)