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A Phase IV Open-Label Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Patients With Spinal Muscular Atrophy After Gene Therapy

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A Phase IV Open-Label Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Patients With Spinal Muscular Atrophy After Gene Therapy

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 23 Feb 2025

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At a glance

  • Drugs Risdiplam (Primary)
  • Indications Spinal muscular atrophy
  • Focus Therapeutic Use
  • Acronyms HINALEA 1
  • Sponsors Roche

    • Most Recent Events

    • 29 Mar 2024 Planned initiation date (estimated date of first participant enrollment) changed from 31 Mar 2024 to 29 Apr 2024.
    • 28 Feb 2024 Planned initiation date (estimated date of first participant enrollment) changed from 7 Feb 2024 to 31 Mar 2024.
    • 14 Feb 2024 Status changed from not yet recruiting to recruiting.

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