Study title: A PHASE IV, OPEN-LABEL, MULTI-CENTER COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF KEPPRA. AS ADJUNCTIVE THERAPY IN ADULT PATIENTS WITH UNCONTROLLED PARTIAL EPILEPSY. S.K.A.T.E. : SAFETY OF KEPPRA. AS ADJUNCTIVE THERAPY IN EPILEPSY.
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Nervous System Diseases | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: levetiracetam | |||||
ATC code: N03AX14 | |||||
Document link: N01031 - Levetiracetam - RRCE04G2602.pdf | |||||
Document date: 2011-11-28 | |||||
Study number: RRCE04G2602 | |||||
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 |