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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 28 Feb 2022

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At a glance

  • Drugs Rasagiline (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 25 Feb 2022 Planned End Date changed from 1 Sep 2016 to 17 Sep 2016.
  • 16 Sep 2020 Results of post-hoc analysis of clinical trials (NCT02337725, NCT02337738) presented at the 24th International Congress of Parkinson's Disease and Movement Disorders
  • 29 Jun 2017 According to a Takeda Pharma media release, based on the data from CCT-001 and CCT-002 studies the company has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for rasagiline mesylate for the treatment of Parkinson's disease.

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