Collaboration in Neonatal Study Addresses and Resolves Multi-Stage Difficulties
Collaboration in Neonatal Study Addresses and Resolves Multi-Stage Difficulties
4 PagesCASE STUDY Collaboration in Neonatal Study Addresses and Resolves Multi-Stage DifficultiesCollaboration in Neonatal Study Addresses and Resolves Multi-Stage Difficulties Primary Endpoint Evaluate the PK of the study drug in neonates who have seizures that are not well controlled with previous treatment. Identify the optimal dosing (first cohort) for the treatment of subjects enrolled into the following cohorts of the study. Client Type Pharmaceutical Indication Neurology, Epilepsy Drug Class Antiepileptic Study Phase II/III Business Segment Product Registration Services Therapeutic Area Neurology Regions Central Europe Western Europe STUDY DESCRIPTION A phase II/III, open-label, multi-center, multi-national study assessing the PK, efficacy, and safety of the study
