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A Phase 3 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease

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Trial Profile

A Phase 3 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2023

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At a glance

  • Drugs Ketamine (Primary)
  • Indications Dyskinesias; Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors PharmaTher
  • Most Recent Events

    • 29 Mar 2023 According to a PharmaTher media release, company announced an update on the Type C meeting with the US FDA for advancing KETARX towards Phase 3 clinical study as a treatment for levodopa-induced dyskinesia in Parkinson disease, the Company plans to adapt its proposed clinical development program to align with the FDA recommendations and the Company resources towards study evaluations leading into a Phase 3 study and a potential FDA marketing approval via the 505(b)(2) regulatory pathway.
    • 01 Feb 2023 According to PharmaTher media release, the company has submitted its meeting package with the U.S. Food and Drug Administration ("FDA") to discuss with the FDA its plans for a Phase 3 clinical study. The Type C meeting is via written responses and FDA written responses expected in March 20, 2023. The Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™.
    • 11 Jan 2023 According to PharmaTher media release, type C meeting is granted by FDA for potential phase III clinical study in the treatment of levodopa-induced dyskinesia in Parkinson patients.
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