A TWO PART SEAMLESS MULTI-CENTER RANDOMIZED PLACEBO CONTROLLED 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 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: 12 Oct 2017

At a glance

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

    • 12 Oct 2017 According to a PTC Therapeutics media release, the company has concluded an exploratory dose finding part (Part 1) and initiated a confirmatory part (Part 2) of this trial.
    • 03 Oct 2017 According to a PTC Therapeutics media release, data from part 1 of this trial were presented at the 22nd International World Muscle (WMS) Congress.
    • 01 Jul 2017 According to a PTC Therapeutics media release, preliminary data from an early analysis of Part 1 of this trial were presented at CureSMA Conference.
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