Study title: A 12 WEEK, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP MULTICENTER STUDY TO DETERMINE THE EFFICACY OF GABAPENTIN (CI-945) 900MG DAILY AND THE DOSE RESPONSE CHARACTERISTICS AND SAFETY OF GABAPENTIN 900MG AND 1200MG ORAL DAILY DOSES AS ADD ON THERAPY IN PATIENTS WITH MEDICALLY REFRACTORY 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 | |||||
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Active substance: GABAPENTIN | |||||
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Study number: 0945-6 | |||||
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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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