Study title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures [Data from the Open-label Continuation Phase]
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases | |||||
Brands: | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: LAMOTRIGINE | |||||
ATC code: | |||||
Document link: Lamotrigine-Lamotrigine-LAM40097-ICHE3.pdf | |||||
Document date: 2011-10-18 | |||||
Study number: LAM40097 (open label) | |||||
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 | - |