Study title: A 26 WEEK DOUBLE-BLIND, DOSE-CONTROLLED, MULTICENTER STUDY OFCONVERSION FROM MARKETED ANTIEPILEPTIC DRUG THERAPY TO GABAPENTIN MONOTHERAPY IN PATIENTS W/ COMPLEX PARTIAL OR SECONDARILY GENERALIZED SEIZURES: .
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases [C10] | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: GABAPENTIN | |||||
ATC code: | |||||
Document link: | |||||
Document date: | |||||
Study number: 0945-000-082 | |||||
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) |
- | - | - | Y | - |