Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo and Active-controlled, Parallel-group, Multicentre Clinical Study

Trial Profile

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo and Active-controlled, Parallel-group, Multicentre Clinical Study

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2018

At a glance

  • Drugs Opicapone (Primary) ; Benserazide; Carbidopa; Entacapone; Levodopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BIPARK-I
  • Sponsors Bial
  • Most Recent Events

    • 31 Jul 2018 According to a Neurocrine Biosciences, Company met with the FDA in January and based upon the BIPARK-I and BIPARK-II pivotal Phase III studies conducted by BIAL, the FDA did not require additional Phase III trials to form an NDA submission.NDA submission which it anticipates will occur during the first half of 2019.
    • 19 Jun 2018 Bosnia-Herzegovina, Croatia, France, Poland, Russia, Serbia, Ukraine were the planned locations for this study.
    • 19 Jun 2018 Results presented at the 4th Congress of the European Academy of Neurology
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