A Phase 4 Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan) for 7 Years
Active, no longer recruiting
Phase of Trial: Phase IV
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Sapropterin (Primary)
- Indications Phenylketonuria
- Focus Therapeutic Use
- Acronyms KOGNITO
- Sponsors BioMarin Pharmaceutical; Merck KGaA
- 08 Apr 2016 Status changed from recruiting to active, no longer recruiting.
- 11 Aug 2015 Planned End Date changed from 1 Apr 2022 to 1 Dec 2022 according to ClinicalTrials.gov record.
- 11 Aug 2015 Planned primary completion date changed from 1 Apr 2022 to 1 Nov 2022 according to ClinicalTrials.gov record.