Status:
COMPLETED
Open-Label Extension Study of Kuvan for Autism
Lead Sponsor:
The Children's Health Council
Collaborating Sponsors:
BioMarin Pharmaceutical
Conditions:
Autistic Disorder
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed 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 subje...
Eligibility Criteria
Inclusion
- All subjects must have completed earlier trial, CHC 0901 (NCT00850070)
- Parents must be willing and able to sign informed consent
Exclusion
- Child failed to complete CHC 0901 (NCT00850070)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00943579
Start Date
August 1 2009
End Date
March 1 2012
Last Update
May 2 2018
Active Locations (1)
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1
The Children's Health Council
Palo Alto, California, United States, 94304