Open-Label Extension Study of Kuvan for Autism

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. During this protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. The purpose of the study primarily is to gather additional information on safety and efficacy in this population. ;

Study Design

Related Conditions & MeSH terms

Autistic Disorder

Clinical Trial Details

NCT number	NCT00943579
Study type	Interventional
Source	The Children's Health Council
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	August 2009
Completion date	March 2012

View Details

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