Open-Label Extension Study of Kuvan for Autism
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 3 - 6 |
| Updated: | 5/4/2018 |
| Start Date: | August 2009 |
| End Date: | March 2012 |
Kuvan® (Sapropterin) as a Treatment for Autistic Disorder: An Open Label Extension Protocol
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.
double-blind, placebo-controlled study of sapropterin in children with autism.
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 subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject
who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose
for up to 90 days after the last subject has completed the first 16 weeks of this protocol.
The purpose of the study primarily is to gather additional information on safety and efficacy
in this population.
double-blind, placebo-controlled study of sapropterin in children with autism. During this
protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject
who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose
for up to 90 days after the last subject has completed the first 16 weeks of this protocol.
The purpose of the study primarily is to gather additional information on safety and efficacy
in this population.
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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