A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

Trial Profile

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2017

At a glance

  • Drugs Pramipexole (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 14 Nov 2012 Planned number of patients changed from 516 to 645 as reported by European Clinical Trials Database (Parent trial: EudraCT2007-000074-23).
    • 17 Apr 2010 Results from the open-label phase following a switch from immediate-release to extended-release pramipexole presented at the 62nd Annual Meeting of the American Academy of Neurology
    • 23 Mar 2010 FDA has approved once-daily MIRAPEX ER for the treatment of idiopathic (early or late) parkinson's disease, according to a Boehringer Ingelheim media release. The FDA approval was supported by this trial.
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