Study title:
A REPORT OF A SINGLE-CENTER, PILOT STUDY COMPRISING A 12-WEEK, PLACEBO CONTROLLED, PARALLEL GROUP, DOUBLE BLIND PHASE, FOLLOWED BY A LONG-TERM, OPEN LABEL PHASE, TO DETERMINE THE EFFICACY AND SAFETY OF GABAPENTIN (CI-945) TAKEN AS ORAL DAILY DOSES AS ADD-ON THERAPY IN JUVENILE PATIENTS WITH MEDICALLY REFRACTORY PARTIAL SEIZURES
Type of medicine: Medicines containing chemical active substances
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Therapeutic area: Nervous System Diseases [C10]
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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:
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Document date:
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Study number: 0945-11* |
EudraCT number:
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Scope of study: Clinical |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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-
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-
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Y
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-
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