Patients complaining of excessive daytime sleepiness will be recruited from our sleep clinics and will be subjected to neuropsychiatric, physical, laboratory and neurophysiological screening examinations (including polysomnography, MSLT as well as HLA typing for DQB1*0602 or DR 2 positivity).
Conditions
Interventions
Pharmaceutical Form:
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Department of Psychiatry; Section of Sleep Research and Pharmacopsychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria call for patients of either sex, satisfying the classification criteria of the International Classification of Sleep Disorders ICSD [2] for narcolepsy. In addition, symptoms are required to have been stable for 2 weeks before the beginning of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patients with evidence of a medical or psychiatric disorder that might account for the primary complaint; patients with sleep apnea, restless legs syndrome (RLS) or periodic limb movement disorder, pregnant or lactating women; patients with a history of drug abuse or dependency, including alcohol; patients requiring psychoactive medication; patients unwilling to temporarily discontinue anticataplectic medication or any other drug that might interfere with the study assessments; patients unable or unwilling to comply with the protocol; patients who work at night
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study intends to investigate the therapeutic efficacy of the psychostimulant modafinil as compared with placebo, utilizing topographic and tomographic EEG/ERP and psychometry, and to determine the respective target regions in the cerebral cortex.;Secondary Objective: ;Primary end point(s): descriptive data analysis with one confirmatory statement in regard to the target variable (alpha 2 power) | — |
Countries
Austria
Outcome results
None listed