Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies (AUTOSOP)
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ClinicalTrials.gov Identifier: NCT00916253 |
Recruitment Status
:
Completed
First Posted
: June 9, 2009
Last Update Posted
: April 25, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy Hypersomnia | Drug: Modafinil Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment. |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Modafinil First
Treatment by Modafinil during first condition then placebo during second condition
|
Drug: Modafinil
Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
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Experimental: Placebo First
Treatment by Placebo during first condition then Modafinil during second condition
|
Drug: Modafinil
Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
|
No Intervention: H
Healthy Volunteers
|
- Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road [ Time Frame: for each condition, at day 4 for patients or day 1 for healthy volonteers ]
- Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]
- nocturnal sleep quality and quantity will be measured by PSG and Actimetry. [ Time Frame: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916253
France | |
GENNPHASS - CHU de Bordeaux | |
Bordeaux, France, 33076 | |
AP-HP - Hôpital de l'Hôtel-Dieu | |
Paris, France, 75181 |
Principal Investigator: | Pierre PHILIP, MD, PHD | University Hospital, Bordeaux |
Publications:
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00916253 History of Changes |
Other Study ID Numbers: |
CHUBX 2008/37 |
First Posted: | June 9, 2009 Key Record Dates |
Last Update Posted: | April 25, 2013 |
Last Verified: | April 2013 |
Keywords provided by University Hospital, Bordeaux:
Sleep real driving simulated driving MWT |
Additional relevant MeSH terms:
Narcolepsy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Modafinil |
Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |