Kuvan®: Clinical Trials

6 completed, 1 terminated. 3 Phase 3, 2 Phase 2, 2 Phase 4, 1 Not applicable.

By phase and status

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Sapropterin on Cognitive Abilities in Young Adults With Phenylketonuria Sapropterin, Placebo - Phenylketonuria	Phase 2	Terminated	BioMarin Pharmaceutical	2	2014-02-01	2018-02-22
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria Kuvan® - Phenylketonuria	Phase 4	Completed	BioMarin Pharmaceutical	34	2013-10-01	2023-04-24
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria Kuvan® - Phenylketonuria	Phase 3	Completed	Merck KGaA, Darmstadt, Germany	90	2012-11-01	2014-07-28
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old Kuvan®, Phenylalanine (Phe)-restricted diet - Phenylketonuria	Phase 3	Completed	BioMarin Pharmaceutical	56	2011-06-01	2017-09-15
Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders sapropterin dihydrochloride - Autism Spectrum Disorder	Not applicable	Completed	The University of Texas Health Science Center, Houston	10	2010-07-01	2014-04-01
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period Kuvan® - Phenylketonuria	Phase 4	Completed	Merck KGaA, Darmstadt, Germany	59	2010-05-01	2014-02-27
Open-Label Extension Study of Kuvan for Autism Kuvan® - Autistic Disorder	Phase 2 / Phase 3	Completed	The Children's Health Council	41	2009-08-01	2018-05-02