A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants (SUNFISH)
A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients
Sponsor: Hoffmann-La Roche
Listed as NCT02908685, this PHASE2 trial focuses on Muscular Atrophy, Spinal and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 42 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
42 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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May 2024 — Jul 2024 [monthly]
Completed PHASE2
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Nov 2023 — May 2024 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed · Phase: PHASE2_PHASE3 → PHASE2
▶ Show 37 earlier versions
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Oct 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Sep 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jun 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2023 — Jun 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Dec 2022 — Apr 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Sep 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2022 — Apr 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Dec 2021 — Jan 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Oct 2021 — Dec 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Sep 2021 — Oct 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Aug 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jul 2020 — Aug 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2020 — Jul 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2020 — Apr 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Oct 2019 — Jan 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jul 2019 — Oct 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
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May 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2019 — May 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2019 — Apr 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2018 — Jan 2019 [monthly]
Recruiting PHASE2_PHASE3
Status: Active Not Recruiting → Recruiting
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Oct 2018 — Nov 2018 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Sep 2018 — Oct 2018 [monthly]
Recruiting PHASE2_PHASE3
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Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE2_PHASE3
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Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE2_PHASE3
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2_PHASE3
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE2_PHASE3
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Mar 2018 — May 2018 [monthly]
Recruiting PHASE2_PHASE3
Phase: PHASE2 → PHASE2_PHASE3
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Feb 2018 — Mar 2018 [monthly]
Recruiting PHASE2
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Jan 2018 — Feb 2018 [monthly]
Recruiting PHASE2
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Nov 2017 — Jan 2018 [monthly]
Recruiting PHASE2
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May 2017 — Nov 2017 [monthly]
Recruiting PHASE2
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Apr 2017 — May 2017 [monthly]
Recruiting PHASE2
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Feb 2017 — Apr 2017 [monthly]
Recruiting PHASE2
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Oct 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Hoffmann-La Roche
For direct contact, visit the study record on ClinicalTrials.gov .