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Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)

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Trial Profile

Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2024

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At a glance

  • Drugs Omigapil (Primary)
  • Indications Congenital disorders; Muscular dystrophies
  • Focus Pharmacokinetics
  • Acronyms CALLISTO
  • Sponsors Santhera Pharmaceuticals
  • Most Recent Events

    • 05 Apr 2018 According to a Santhera Pharmaceuticals media release, the preparation and conduct of this CALLISTO trial was supported financially by a public-private partnership including two patient organizations, the US-based Cure CMD and the Swiss Foundation for Research on Muscle Diseases (FRSMM), EndoStem, an EU 7th Framework program, and NIH clinical resources.
    • 05 Apr 2018 According to a Santhera Pharmaceuticals media release, the company will share detailed data from the CALLISTO trial at upcoming scientific conferences and with the patient community.
    • 05 Apr 2018 Primary endpoint has been met. (To establish the pharmacokinetic profile of omigapil at a range of doses in paediatric and adolescent patients with CMD)
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