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A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy

Study acronym: HINALEA 2
StatusRecruiting
PhasePhase 4
Started2024-08-14
View on ClinicalTrials.gov ↗
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene abeparvovec and experience a plateau or decline in function. Participants to be enrolled are children \<2 years of age genetically diagnosed with SMA.

Amendment record

Amended 44 times since 2023-05-08; most recent filed 2026-08-10. 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.

2026-08-10
Amendment Study Status, Contacts/Locations v44
2026-07-08
Amendment Study Status, Contacts/Locations v43
2026-06-05
Amendment Study Status, Contacts/Locations, References v42
2026-05-07
Amendment Study Status v41
2026-04-10
Amendment Study Status v40
2026-03-12
Amendment Study Status v39
2026-02-12
Amendment Study Status v38
2026-01-15
Amendment Study Status v37
2025-12-19
Amendment Study Status v36
2025-11-21
Amendment Study Status v35
2025-10-23
Amendment Study Status v34
2025-09-24
Amendment Study Status, Contacts/Locations v33
2025-08-26
Amendment Study Status v32
2025-07-28
Amendment Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v31
2025-06-12
Amendment Study Status v30
2025-05-12
Amendment Study Identification, Study Status v29
2025-04-11
Amendment Study Status v28
2025-03-13
Amendment Study Status, Contacts/Locations v27
2025-02-14
Amendment Study Status, Contacts/Locations v26
2025-01-15
Amendment Study Status, Contacts/Locations v25
2024-12-20
Amendment Study Status v24
2024-11-21
Amendment Study Status v23
2024-10-25
Amendment Study Status v22
2024-09-26
Amendment Study Status, Contacts/Locations v21
2024-08-27
Amendment Study Status v20
2024-08-05
Amendment Study Status, Contacts/Locations v19
2024-07-04
Amendment Study Status, Contacts/Locations v18
2024-06-07
Amendment Study Status v17
2024-05-10
Amendment Study Status, Contacts/Locations v16
2024-04-25
Amendment Study Status v15
2024-03-29
Amendment Study Status v14
2024-03-12
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v13
2024-02-20
Amendment Study Status, Outcome Measures v12
2024-02-08
Amendment Study Status v11
2024-01-18
Amendment Study Status v10
2023-12-27
Amendment Study Status v9
2023-12-21
Amendment Study Status v8
2023-11-30
Amendment Study Status v7
2023-11-02
Amendment Study Status v6
2023-10-05
Amendment Study Status v5
2023-09-05
Amendment Study Identification, Study Status, Outcome Measures, Eligibility v4
2023-08-16
Amendment Study Status v3
2023-07-19
Amendment Study Status v2
2023-06-19
Amendment Study Status v1
2023-05-08
Original filing
Trial Details
NCT Number NCT05861999
Lead Sponsor Hoffmann-La Roche
Conditions Muscular Atrophy, Spinal
Enrollment 28 participants
Start Date 2024-08-14
Primary Completion 2028-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11