drugset / Trial / NCT01413711

An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

NCT01413711

Phase 4 Withdrawn Lundbeck LLC
NaSingle-groupOpen-label

Summary

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.

Timeline

Start
2012-06
Primary completion
2013-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Vigabatrin Small molecule 25 mg/kg Oral

Indications