Open-Label Extension Study of Kuvan for Autism

Summary

This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.

Timeline

Start

2009-08

Primary completion

2011-12

Completion

2012-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Kuvan Following Placebo vs Kuvan Following Active Treatment; p >.05; Chi-squared NCT00943579 ↗

Drugs

Indications