Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
NCT ID: NCT00916253
Last Updated: 2013-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2010-03-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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Modafinil First
Treatment by Modafinil during first condition then placebo during second condition
Modafinil
Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Placebo
Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
Placebo First
Treatment by Placebo during first condition then Modafinil during second condition
Modafinil
Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Placebo
Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
H
Healthy Volunteers
No interventions assigned to this group
Interventions
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Modafinil
Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Placebo
Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
* during 3 days at home
* during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Pierre PHILIP, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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GENNPHASS - CHU de Bordeaux
Bordeaux, , France
AP-HP - Hôpital de l'Hôtel-Dieu
Paris, , France
Countries
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References
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Other Identifiers
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CHUBX 2008/37
Identifier Type: -
Identifier Source: org_study_id
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