Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05232929 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

Study acronym: WeSMA
StatusActive, Not Recruiting
PhasePhase 4
Started2022-03-29
View on ClinicalTrials.gov ↗
A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Information (USPI) in adult and pediatric participants with SMA. In this study, participants will be followed for approximately 24 months from enrollment or until withdrawal of consent, loss to follow-up, or death. Participants who discontinue risdiplam may still remain in the study if they agree to continue participating in the follow-up assessments. An optional sub-study was planned to assess the feasibility, acceptability, and adherence of remote assessment of motor and bulbar functions in participants with SMA using wearable and smartphone-based biosensors. This substudy was withdrawn upon implementation of protocol version 4.

Amendment record

Amended 45 times since 2022-01-31; most recent filed 2026-07-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-15
Amendment Study Status v45
2026-04-17
Amendment Study Status, Study Design v44
2026-04-16
Amendment Study Status v43
2026-01-15
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v42
2025-11-26
Amendment Study Status v41
2025-08-28
Amendment Study Status v40
2025-05-30
Amendment Study Status v39
2025-03-04
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, IPDSharing v38
2025-02-03
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v37
2024-12-23
Amendment Study Identification, Study Status, Oversight, Study Description, Outcome Measures, Eligibility v36
2024-10-18
Amendment Study Status v35
2024-09-17
Amendment Study Status, Contacts/Locations v34
2024-08-19
Amendment Study Status v33
2024-07-18
Amendment Study Status v32
2024-06-21
Amendment Study Status v31
2024-05-24
Amendment Study Status, Contacts/Locations v30
2024-04-25
Amendment Study Status, Contacts/Locations v29
2024-03-28
Amendment Study Status, Contacts/Locations v28
2024-02-27
Amendment Study Status, Contacts/Locations v27
2024-02-08
Amendment Study Status v26
2024-01-18
Amendment Study Status, Contacts/Locations v25
2023-12-21
Amendment Study Status v24
2023-11-30
Amendment Study Status, Contacts/Locations v23
2023-11-02
Amendment Study Status, Contacts/Locations v22
2023-10-05
Amendment Study Status, Contacts/Locations v21
2023-09-11
Amendment Study Status v20
2023-08-16
Amendment Study Status v19
2023-07-19
Amendment Study Status, Contacts/Locations v18
2023-06-19
Amendment Study Status, Contacts/Locations v17
2023-05-04
Amendment Study Status, Contacts/Locations v16
2023-04-10
Amendment Study Status v15
2023-03-16
Amendment Study Status, Contacts/Locations v14
2023-02-16
Amendment Study Status, Contacts/Locations v13
2023-01-18
Amendment Study Status, Contacts/Locations v12
2022-12-21
Amendment Study Status, Contacts/Locations v11
2022-11-22
Amendment Study Status, Contacts/Locations v10
2022-10-26
Amendment Study Status, Contacts/Locations v9
2022-09-28
Amendment Study Status, Contacts/Locations v8
2022-08-30
Amendment Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v7
2022-08-02
Amendment Study Status, Contacts/Locations v6
2022-07-07
Amendment Study Status v5
2022-06-09
Amendment Study Status, Contacts/Locations v4
2022-05-11
Amendment Study Status v3
2022-04-14
Amendment Study Status v2
2022-03-16
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2022-01-31
Original filing
Trial Details
NCT Number NCT05232929
Lead Sponsor Genentech, Inc.
Conditions Spinal Muscular Atrophy
Enrollment 403 participants
Start Date 2022-03-29
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16