CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Kuvan®drug
Likely dose
Kuvan® 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00943579
NCT00943579Phase 3Completed
CompareCT.gov

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

The Children's Health Council·interventional·Posted Jul 22, 2009·Updated May 2, 2018

In Brief

A Phase 3 clinical trial evaluating Kuvan® for Autistic Disorder. Completed, enrolled 41 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesUnited States
CollaboratorsBioMarin Pharmaceutical

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2009
Enrollment StartAug 1, 2009
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.9 years ago

Interventions

Kuvan®drug

Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks.