NCT04120493

A Phase 1/2, Randomized, Double-Blind, Sham Control and Open-Label Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT-130) in Early Manifest Huntington's Disease

Study Summary

This is the first study of AMT-130 in patients with early manifest HD and is designed to establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase 1/2, multicenter, first-in-human (FIH) study. The first three cohorts of the study have completed enrollment, including the randomized, double-blind, sham-controlled cohorts. Cohort 4 is open-label. Cohort 4 participants will receive high dose AMT-130.

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Interventions

intra-striatal rAAV5-miHTTGENETIC
One time MRI-guided stereotaxic infusion of rAAV5-miHTT into the brain
Imitation (sham) surgeryOTHER
Simulated surgical procedure with skin incisions only; no intrastriatal injections and no burr holes through the skull

Study Locations

FacilityCityStateCountry
University of Alabama at BirminghamBirminghamAlabamaUnited States
University of Arizona (Surgical Site Only)TucsonArizonaUnited States
University of California, San FranciscoSan FranciscoCaliforniaUnited States
CenExel Rocky Mountain Clinical ResearchEnglewoodColoradoUnited States
Rush University Medical CenterChicagoIllinoisUnited States
Johns Hopkins UniversityBaltimoreMarylandUnited States
University of Michigan Department of NeurologyAnn ArborMichiganUnited States
Ohio State UniversityColumbusOhioUnited States
Vanderbilt University Medical CenterNashvilleTennesseeUnited States
The University of TexasHoustonTexasUnited States
Virginia Commonwealth University VCU School of Medicine, Department of NeurologyRichmondVirginiaUnited States
University of Washington Medical CenterSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026