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

NCT06826612 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-05-05

No results posted yet for this study

Summary

The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.

Conditions

  • Huntington Disease

Interventions

GENETIC

SPK-10001

Specified dose on specified days

OTHER

Placebo Surgery Control

Placebo Surgery procedure for SPK-10001

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-LaRoche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2035-01-12
Completion
2035-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06826612 on ClinicalTrials.gov