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A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

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Trial Profile

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2024

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At a glance

  • Drugs Levodopa/carbidopa (Primary) ; Levodopa/carbidopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms RISE-PD
  • Sponsors Amneal Pharmaceuticals; IMPAX Laboratories

    • Most Recent Events

    • 07 Aug 2024 According to an Amneal Pharmaceuticals media release, company receives U.S. FDA Approval for IPX203 for Treatment of Parkinson's Disease to Be Launched as CREXONT (Carbidopa and Levodopa) Extended-Release Capsules
    • 18 Apr 2024 Results assessing safety profile of IPX203 in Patients exposed for 12 Months, presented at the 76th Annual Meeting of the American Academy of Neurology 2024
    • 18 Apr 2024 Results assessing the safety and efficacy of IPX203 vs IR CD-LD in PD patients with motor fluctuations, presented at the 76th Annual Meeting of the American Academy of Neurology 2024.

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