Open-Label Extension Study of Kuvan for Autism

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Children's Health Council
• Collaborator: BioMarin Pharmaceutical
• Treatments: Verapamil

Criteria

Inclusion Criteria:

• All subjects must have completed earlier trial, CHC 0901 (NCT00850070)

• Parents must be willing and able to sign informed consent

Exclusion Criteria:

• Child failed to complete CHC 0901 (NCT00850070)