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Open-Label Extension Study of Kuvan for Autism

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Trial Status Completed

Trial Identifier

NCT00943579

Condition

Autistic Disorder

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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.

Eligibility Criteria

Birth Sex

All

Age

3 Years to 6 Years

Healthy Volunteers

No

Drug/Treatment:

Kuvan®

Phase:

Phase 2/Phase 3

Study Type:

Interventional

Number of Participants:

41

Study Started:

2009-08

Study Updated:

2018-05-02

Trial Locations

  • The Children's Health Council

    Palo Alto, California, United States

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

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