A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients

Trial Profile

A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients

Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Nov 2017

At a glance

  • Drugs RG 7916 (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SUNFISH
  • Sponsors Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 09 Nov 2017 Planned End Date changed from 31 May 2020 to 5 May 2020.
    • 20 Oct 2017 Protocol was amended to change the design keywords from parallel to sequential and change in treatment groups.
    • 20 Oct 2017 Planned number of patients changed from 218 to 219.
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