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

Trial Profile

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: 08 Jun 2016

At a glance

  • Drugs Sapropterin (Primary)
  • Indications Phenylketonuria
  • Focus Therapeutic Use
  • Acronyms KOGNITO
  • Sponsors BioMarin Pharmaceutical; Merck KGaA
  • Most Recent Events

    • 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.
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