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Last Updated: December 7, 2021

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CLINICAL TRIALS PROFILE FOR RISDIPLAM

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All Clinical Trials for risdiplam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02633709 ↗ A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers Completed Hoffmann-La Roche Phase 1 2016-01-07 The objective of this study is to assess the safety and tolerability of Risdiplam (RO7034067) in healthy people. The study will assess what the body does to Risdiplam (RO7034067) and what Risdiplam (RO7034067) does to the body. Risdiplam (RO7034067) will be given by mouth in gradually increasing doses. The data from this study will help to define the dose to further explore Risdiplam (RO7034067) in patients with Spinal Muscular Atrophy.
NCT02908685 ↗ A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants Active, not recruiting Hoffmann-La Roche Phase 2/Phase 3 2016-10-20 Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.
NCT02913482 ↗ Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy Active, not recruiting Hoffmann-La Roche Phase 2/Phase 3 2016-12-24 Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding part (Part 1) and a confirmatory part (Part 2) which will investigate Risdiplam (RO7034067) for 24-months at the dose selected in Part 1.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for risdiplam

Condition Name

Condition Name for risdiplam
Intervention Trials
Muscular Atrophy, Spinal 5
Spinal Muscular Atrophy 4
Healthy Volunteers 1
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Condition MeSH

Condition MeSH for risdiplam
Intervention Trials
Muscular Atrophy 9
Atrophy 9
Muscular Atrophy, Spinal 9
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Clinical Trial Locations for risdiplam

Trials by Country

Trials by Country for risdiplam
Location Trials
United States 20
Italy 13
Brazil 6
Spain 4
Canada 4
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Trials by US State

Trials by US State for risdiplam
Location Trials
Florida 4
New York 4
California 4
Texas 3
Massachusetts 2
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Clinical Trial Progress for risdiplam

Clinical Trial Phase

Clinical Trial Phase for risdiplam
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for risdiplam
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 3
Recruiting 2
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Clinical Trial Sponsors for risdiplam

Sponsor Name

Sponsor Name for risdiplam
Sponsor Trials
Hoffmann-La Roche 9
Biogen 1
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Sponsor Type

Sponsor Type for risdiplam
Sponsor Trials
Industry 10
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