Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases [C10] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: TOPIRAMATE | |||||
ATC code: N03AX11 | |||||
Document link: | |||||
Document date: | |||||
Study number: 5. TOPMAT-MIGR-002 | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
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) |
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