SIGNAL: A new investigational approach to early treatment of Huntington’s disease

The SIGNAL trial is designed to assess the safety, tolerability, and effectiveness of VX15, a novel monoclonal antibody in people with the gene mutation that causes HD who either have early signs of Huntington’s disease (HD)  or have not yet been diagnosed. It is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study at 20 sites across the United States that seeks to enroll approximately 84 individuals, 21 or older, who are either early in the progression of the disease or are not yet diagnosed with the disease. 

The study procedures involves:
* A screening visit to confirm eligibility. Approved subjects will complete a baseline visit and then begin the investigational period 
* Once a month drug or placebo delivery through an approximately hour-long intravenous infusion 
* Brain imaging and cognitive testing during specified visits – these monthly visits may take a full day to complete 
* Safety, tolerability, and efficacy assessments will be performed at all visits
* Subjects will be treated with drug or placebo intravenous infusion for 12-18 months