Pilot study on therapeutic efficacy of modafinil in idiopathic hypersomnie
- Conditions
- 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.
- Registration Number
- EUCTR2008-007033-41-DE
- Lead Sponsor
- Hephata-Klinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
PSG and MSLT done in the past 5 years
(MSLT <2 SOREM phases, sleep latency < 8 min)
18-65 years of age
Hypocretin-1 > 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
IH with long sleep time
Narcolepsy without cataplexy, hypocretin-1 < 110mg/ml (if measured)
Sleep related breathing disorders (AHU > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method