An international, multicenter, randomized, evaluator-blinded, no-treatment controlled, parallel-group study to assess the efficacy and safety of once daily nitisinone in patients with alkaptonuria after 12 months of treatment, followed by an additional 36-month treatment period.

Trial Profile

An international, multicenter, randomized, evaluator-blinded, no-treatment controlled, parallel-group study to assess the efficacy and safety of once daily nitisinone in patients with alkaptonuria after 12 months of treatment, followed by an additional 36-month treatment period.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2016

At a glance

  • Drugs Nitisinone (Primary)
  • Indications Inborn error amino acid metabolic disorders
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 28 Jan 2016 Status changed from recruiting to active, no longer recruiting as per United Kingdom Clinical Research Network.
    • 17 Mar 2015 Planned End Date changed from 31 Mar 2015 to 1 Mar 2015 as per United Kingdom Clinical Research Network.
    • 10 Mar 2015 Planned End Date changed from 1 Mar 2015 to 31 Mar 2015 as reported by United Kingdom Clinical Research Network record.
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