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Completed Phase 2Phase 3 Interventional Results available

Open-Label Extension Study of Kuvan for Autism

ClinicalTrials.gov ID: NCT00943579

Public ClinicalTrials.gov record NCT00943579. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Kuvan® (Sapropterin) as a Treatment for Autistic Disorder: An Open Label Extension Protocol

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00943579
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Enrollment
41 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
3 Years to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2009
Primary completion
Nov 30, 2011
Completion
Feb 29, 2012
Last update posted
May 1, 2018

2009 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Children's Health Council Palo Alto California 94304

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00943579, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 1, 2018 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00943579 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →