Open-Label Extension Study of Kuvan for Autism

Completed · Phase 2/Phase 3

Conditions studied: Autistic Disorder

In brief

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.

Key facts

Study ID

NCT00943579

Run by

The Children's Health Council

People needed

41

Starts

2009-08-01

Expected to finish

2012-03-01

Last updated by the study team

2018-05-02

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects must have completed earlier trial, CHC 0901 (NCT00850070)
• Parents must be willing and able to sign informed consent

You may not qualify if…

• Child failed to complete CHC 0901 (NCT00850070)

Where it is running

• The Children's Health Council — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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