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NCT06826612
A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease
Phase 1, PHASE2 trial testing SPK-10001 in Huntington Disease in 53 participants. Currently enrolling.
12 January 2035
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 21 February 2025 |
| Primary completion | 12 January 2035 |
| Estimated completion | 12 January 2035 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- SPK-10001
- Placebo Surgery Control
Conditions studied
- Huntington Disease — all drugs for Huntington Disease →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 25 to 65, any sex, with Huntington Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current trends in gene therapy to treat inherited disorders of the brain.
Matuszek Z, Brown BL, Yrigollen CM, Keiser MS, et al · · 2025 · cited 6× · PMID 40181540 · DOI 10.1016/j.ymthe.2025.03.057 -
Huntington's disease clinical trials update: October 2025.
Farag M, Tabrizi SJ, Wild EJ. · · 2026 · PMID 41295902 · DOI 10.1177/18796397251399751 -
Brain organoid models of Huntington's disease shift the focus towards neurodevelopment.
Xu W, Prigione A. · · 2025 · PMID 41147161 · DOI 10.1242/dmm.052510
Verify or expand the search:
- PubMed search for NCT06826612
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Huntington Disease
Currently open trials in the same condition.
- NCT07326709 — A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease · Phase 3 · recruiting
- NCT07253038 — Evaluation of Three Tests to Assess Social Cognition in Huntington Disease · recruiting
- NCT06774443 — Hinting Task for Huntington's Disease · recruiting
- NCT06546488 — Cognitive Assessment Tools for Huntington's Disease. · recruiting
- NCT07010705 — Digital Measures for Clinical Trial Endpoints in Huntington's Disease · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
- NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06826612 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06826612.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing