Phase 3
Completed N=41
Open-Label Extension Study of Kuvan for Autism
Autistic Disorder
Source: ClinicalTrials.gov NCT00943579 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Clinical Global Impressions Scale — 3; 3 # participants much - very much improved — p=>.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impressions Scale |
3; 3 | >.05 |
| SECONDARY Vineland Adaptive Behavior Scale, 2nd Edition |
275; 321 | — |
| SECONDARY Children's Yale Brown Obsessive Compulsive Scale |
— | — |
| SECONDARY Parental Global Assessment |
— | — |
| SECONDARY Preschool Language Scale, 4th Edition (PLS-4) |
57.24; 77.83 | — |
| SECONDARY Connor's Preschool ADHD Questionnaire |
— | — |
| SECONDARY Aberrant Behavior Checklist (ABC) |
16.84; 9.70 | — |
| SECONDARY Adverse Events Reporting |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00943579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.