An interventional study of Modafinil and Placebo in Narcolepsy and Hypersomnia, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
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Among 10 studies testing modafinil in Narcolepsy — none open to participants now, none under way, none of them phase 3. Modafinil · Narcolepsy.
Among the 10 studies testing modafinil in Narcolepsy, this one is the 10th largest by enrollment, is the only one that started in 2010, is one of 2 with no phase, and was the 9th registered.
158 studies on the registry are indexed under Narcolepsy; 38 are open to participants now.
Browse Narcolepsy studies →None of the 10 studies testing modafinil in Narcolepsy is open now. The open studies under Narcolepsy, anywhere →
Modafinil: first FDA approval 1998 (PROVIGIL). What it is approved for, and how studies give it, is on its page →
Of the 30 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2010.
This study's enrollment of 27 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.
Median enrollment 168 across the 10 interventional studies. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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8 of 10 have an industry lead sponsor. The 5 most frequent:
University Hospital, Bordeaux is the lead sponsor of 807 studies on the registry; 198 are open to participants now.
University Hospital, Bordeaux has 1 study filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing modafinil in Narcolepsy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving
Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck accidents on French Freeways. Since the publication of a new law (arrêté du 28 décembre 2005 du journal officiel) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in narcoleptics and hypersomniacs. Furthermore, even if alerting drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from narcolepsy and hypersomnia. Inclusion of healthy volunteers will allow to collect reference data about somnolence during MWT.
Inclusion Criteria for Patients:
Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Patients:
Exclusion Criteria for Healthy Volunteers:
Treatment by Modafinil during first condition then placebo during second condition
Drug: Modafinil · Drug: Placebo
Treatment by Placebo during first condition then Modafinil during second condition
Drug: Modafinil · Drug: Placebo
Healthy Volunteers
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 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.
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
The record gives a start of Mar 2010, a primary completion of Jul 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modafinil
University Hospital, Bordeaux →