To test the efficacy, tolerability and safety of modafinil for the treatment of of excessiv daytime sleepiness in patients with idiopathic hypersomnia without long sleep time.
Conditions
Interventions
Trade Name: Vigil
Product Name: Vigil
Product Code: 34134.00.00
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
INN or Proposed INN: Modafinil
Concentration unit: mg milligram(s)
Conce
Sponsors
Hephata-Klinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PSG and MSLT done in the past 5 years (MSLT 110pg/ml (if measured) Clinical manifestation at the age between 10 and 30 Free of stimulant treatment for one week prior first study medication 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: IH with long sleep time Narcolepsy without cataplexy, hypocretin-1 15/h) PLMD Circadian rhythm sleep disorders Chronic fatigue sydrome Hypersomnia due to other medical or psychological conditions -hypersomnia du to dysthymia or affektive disorders - hypersomnie after viral infection -posttraumatic hypersomnia Long sleeper Isolated sleep drunkeness Pregnancy Consumptive disorders Treatment with stimulants (no exclusion criterium if treatment has been stopped one week prior first study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy, tolerability and safety of modafinil for the treatment of excessive daytime sleepiness in patients with idiopathic hypersomnia without long sleep time;Secondary Objective: none;Primary end point(s): change in the score of Epworth Sleepiness Scale (standardised scale for evaluation of subjective sleepiness | — |
Countries
Germany
Outcome results
None listed