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An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Trial Profile

An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jul 2023

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At a glance

  • Drugs Rovatirelin (Primary)
  • Indications Spinocerebellar ataxias
  • Focus Therapeutic Use
  • Sponsors Kissei Pharmaceutical
  • Most Recent Events

    • 19 Jul 2023 According to Kissei Pharmaceutical media release, the company decided to temporarily withdraw the application for marketing approval and discuss the possibility of conducting additional clinical trials with the Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA has recently expressed its opinion that the marketing approval based on the current clinical trial data would be difficult.
    • 22 Jan 2020 Results published in Kissei Pharmaceutical Media Release
    • 22 Jan 2020 According to Kissei Pharmaceutical media release, results from this trial been published in a medical journal, the online version of the Journal of Neurology, Neurosurgery, and Psychiatry
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