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A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease

StatusRecruiting
PhasePhase 1/2
Started2025-02-21
View on ClinicalTrials.gov ↗

Amendment history

2026-04-29
Study Status, Contacts/Locations v9
Study sitescontacts updated at 3 of 5 sites
2026-04-14
Study Identification, Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 5 sites
2026-01-26
Study Status, Contacts/Locations v7
Study sites3→5
2025-12-16
Study Identification, Study Status, Sponsor/Collaborators v6
Lead sponsorSpark Therapeutics, Inc.→Hoffmann-La Roche
2025-10-22
Study Status, Oversight v5
Re-verified, no change to tracked fields
Show 4 earlier versions
2025-07-02
Study Status, Contacts/Locations v4
Study sites2→3
2025-05-19
Study Identification, Study Status, Contacts/Locations v3
Study sites1→2
Study titlerevised
A Randomized Study of SPK-10001 Gene Therapy in Participants withWith Huntington's Disease
2025-03-19
Study Identification, Study Status, Oversight, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
Study titlerevised
A Randomized Study of SPK-10001 Gene Therapy in Participants Withwith Huntington's Disease
2025-02-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-28→confirmed 2025-02-21
Study sites0→1
2025-02-10
Original filing
The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.
Trial Details
NCT Number NCT06826612
Lead Sponsor Hoffmann-La Roche
Conditions Huntington Disease
Enrollment 53 participants
Start Date 2025-02-21
Primary Completion 2035-01-12 (estimated)
Study Completion 2035-01-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-05