drugset / Trial / NCT01413711
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vigabatrin | Small molecule | 25 mg/kg | Oral |