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An Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Risdiplam (RO7034067) in Adult and Pediatric Patients With Spinal Muscular Atrophy

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Trial Profile

An Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Risdiplam (RO7034067) in Adult and Pediatric Patients With Spinal Muscular Atrophy

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Risdiplam (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms Jewelfish
  • Sponsors Roche
  • Most Recent Events

    • 22 Jun 2023 This trial has been completed in Germany.
    • 22 Jun 2023 This trial has been completed in Germany.
    • 06 May 2023 Results assessing the in vivo FMO3 ontogeny by mechanistic population pharmacokinetic (Mech-PPK) modelling of risdiplam using the data collected healthy individuals or SMA patients who participated in five clinical trials (NCT02633709, NCT03032172, NCT02908685, NCT02913482, NCT03988907, published in the Clinical Pharmacokinetics.
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