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Can a wakefulness drug make driving safer for sleepy patients?

NCT ID NCT00916253

Knowledge-focused Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how the drug modafinil affects driving ability in 27 people with narcolepsy or hypersomnia. Participants took modafinil or a placebo for five days, then completed both simulated and real driving tests. The goal was to see if the drug improves alertness and reduces driving risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modafinil
What this could lead to
If successful, this study could help doctors understand whether modafinil improves driving safety in people with sleep disorders.
What could go wrong
This is a small, early-stage study with only 27 participants, so results may not apply to everyone. It focuses on measuring driving ability, not on curing or treating the underlying condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Start date

Mar 2010

Finished

Aug 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Patients: * Narcoleptic patients with or without cataplexy or hypersomniacs * aged from 18 to 65 years, * treated for attacks of cataplexy, * treated with a maximum dose of Modiodal: 400 mg per day (4 tablets of 100mg), * without any other disease which could be responsible of excessive daytime sleepiness, * having their driver's licence, * driving more than 5000 Km/year, * registered to French national health and pensions organization, * having regular timetables of life 7 days before beginning the study, * having given their written light agreement in order to participate in the study. Inclusion Criteria for Healthy Volunteers: * without any sleep disorders, * having their driver's licence since at least 2 years, * driving more than 5000 Km/year, * registered to French national health and pensions organization, * having regular timetables of life 7 days before beginning the study, * having given their written light agreement in order to participate in the study. Exclusion Criteria for Patients: * Night workers, * breast-feeding or pregnant women * Beck's scale score \< 8, * neurologic disease, * cardiovascular disorders including cardiac arrhythmia, * sleep disorders except narcolepsy and hypersomnia, * pulmonary disorders, * renal disorders, * endocrinal disorders, * having participated in a clinical study during the last 6 months, * unable to drive. Exclusion Criteria for Healthy Volunteers: * Night workers, * neurologic disease, * cardiovascular disorders, * sleep disorders, * pulmonary disorders, * renal disorders, * endocrinal disorders, * having participated in a clinical study during the last 6 months, * unable to drive.

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence hypersomnia narcolepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypersomnia Narcolepsy

Contacts and locations

Locations

  • AP-HP - Hôpital de l'Hôtel-Dieu

    Paris, 75181, France

  • GENNPHASS - CHU de Bordeaux

    Bordeaux, 33076, France

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