POST-ASPHYCTIC ENCEPHALOPATHY MedDRA version: 9.1 Level: SOC Classification code 10029205 MedDRA version: 9.1 Level: SOC Classification code 10029205
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Topiramate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Sponsors
AZIENDA OSPEDALIERA MEYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MODERATE-SEVERE ASPHYXIA IN TERM NEWBORNS Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: CONGENITAL ABNORMALITIES (CEREBRAL MALFORMATIONS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE POSSIBLE NEUROPROTECTIVE ADDITIVE EFFECT BETWEEN HYPOTHERMIA TREATMENT COMBINATED WITH ORAL TOPIRAMATE ADMINISTRATION: REDUCTION OF MORTALITY AND SEVERE NEUROLOGIC DISABILITY;Secondary Objective: PSYCHOMOTOR EVALUATION AT 18 MONTHS MULTIPLE DISABILITY;Primary end point(s): MORTALITY AND NEURODEVELOPMENT SCORE AT 18 MONTHS OF LIFE | — |
Countries
Italy
Outcome results
None listed