Kuvan®

DRUG5 trials

Sponsors

The Children's Health Council, Merck KGaA, Darmstadt, Germany, BioMarin Pharmaceutical

Conditions

Autistic DisorderPhenylketonuria

Phase 2

Open-Label Extension Study of Kuvan for Autism

CompletedNCT00943579

The Children's Health CouncilAutistic Disorder

Start: 2009-08-31End: 2012-03-31Updated: 2018-05-02

Phase 3

Kuvan® in Phenylketonuria Patients Less Than 4 Years Old

CompletedNCT01376908

BioMarin PharmaceuticalPhenylketonuria

Start: 2011-06-30End: 2017-02-17Updated: 2017-09-15

Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria

CompletedNCT01732471

Merck KGaA, Darmstadt, GermanyPhenylketonuria

Start: 2012-11-30End: 2013-10-31Updated: 2014-07-28

Phase 4

Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period

CompletedNCT01082328

Merck KGaA, Darmstadt, GermanyPhenylketonuria

Start: 2010-05-31End: 2012-05-31Updated: 2014-02-27

Kuvan®'s Effect on the Cognition of Children With Phenylketonuria

CompletedNCT01965912

BioMarin PharmaceuticalPhenylketonuria

Start: 2013-10-31End: 2023-01-04Updated: 2023-04-24

Related Papers

Long-term efficacy and safety of sapropterin in patients who initiated sapropterin at < 4 years of age with phenylketonuria: results of the 3-year extension of the SPARK open-label, multicentre, randomised phase IIIb trial.

2021-08-0319 citations

Efficacy, safety and population pharmacokinetics of sapropterin in PKU patients <4 years: results from the SPARK open-label, multicentre, randomized phase IIIb trial.

2017-03-0931 citations