Study title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of PROVIGIL® (Modafinil) Treatment (100, 200 and 400mg/day) in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases | |||||
Brands: | |||||
MAH holders: | |||||
Assessment: | |||||
Active substance: MODAFINIL | |||||
ATC code: N06BA07 | |||||
Document link: EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls | |||||
Document date: 2011-09-19 | |||||
Study number: C1538/3027/NA/MN | |||||
EudraCT number: | |||||
Scope of study: | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | - |