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Sapropterin as a Treatment for Autistic Disorder

NCT00850070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-05-01

Study results available
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Summary

This study is intended to provide a definitive test of the hypothesis that elevating sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in the CNS will result in measurable improvements in core symptoms of autism in young individuals, under age 6 years. The study will entail a double-blind, placebo-controlled 16-week intervention.

Conditions

  • Autistic Disorder

Interventions

DRUG

sapropterin

Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks

DRUG

Placebo

Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.

Sponsors & Collaborators

Principal Investigators

  • Glen R Elliott, Ph.D., M.D. · The Children's Health Council

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850070 on ClinicalTrials.gov