A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"

Trial Profile

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"

Discontinued
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Tozadenant (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions
  • Sponsors Biotie Therapies Corp.
  • Most Recent Events

    • 20 Nov 2017 Status changed from suspended to discontinued, according to an Acorda Therapeutics media release. The company is discontinuing dosing of all participants based on previously disclosed agranulocytosis and associated serious adverse events. the Company concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety.
    • 15 Nov 2017 Status changed from recruiting to suspended, according to an Acorda Therapeutics media release as the company has paused new enrollment in the study, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the United States Food and Drug Administration (FDA). The Company took this action in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death.
    • 01 Aug 2017 Status changed from not yet recruiting to recruiting.
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