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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)

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: 23 Sep 2019

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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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