RecruitingPhase 1Phase 2NCT06826612

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

A Phase 1/2, Randomized, Sequential, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of a One-Time, Bilateral, Intraparenchymal Infusion of SPK-10001 Into the Caudate and Putamen in Participants With Huntington's Disease


Sponsor

Hoffmann-La Roche

Enrollment

53 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo Surgery Control and SPK-10001 for people with huntington disease. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 25 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICSPK-10001

Specified dose on specified days

OTHERPlacebo Surgery Control

Placebo Surgery procedure for SPK-10001


Locations(5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Cincinnati/Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburg

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06826612


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