A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2017

At a glance

  • Drugs Tozadenant (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TOZ-PD
  • Sponsors Acorda Therapeutics; Biotie Therapies Corp.
  • Most Recent Events

    • 25 Nov 2017 This trial has been suspended in Austria.
    • 20 Nov 2017 According to an Acorda Therapeutics media release, over 90% of the participants in the study have completed the study. The Company expects data from these participants in the first quarter of 2018 and to present these at appropriate medical/scientific venues.
    • 20 Nov 2017 Status changed from active, no longer recruiting 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.
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