A team of scientists at the University of Louisville are determined to find out if a promising treatment, VX15, an investigational monoclonal antibody, can delay the onset of or slow disease progression of Huntington’s Disease (HD). The study titled SIGNAL is a Phase II clinical trial that aims to determine the drug’s safety, tolerability and efficacy profile in patients who are either at risk of developing HD or have just recently been diagnosed with the disease.
The study will be led by the director of the Parkinson’s and Movement Disorders Clinic at UofL Physicians, Kathrin LaFaver, M.D., and Raymond Lee Lebby Chair for Parkinson’s Disease Research in the Department of Neurology at the University of Louisville, which is only 1 of 23 SIGNAL sites across the country.
According to previous preclinical studies, animal models of HD exhibited the tendency of monoclonal antibodies to bind to and suppress a molecule responsible for inflammation in HD patients’ brains. The UofL scientists are looking into the potential of VX15 in guarding against the inflammation that drives degradation in HD patients’ thought, mobility, and behavioral affectations.
Dr. LaFaver and Lebby will be leading the first research to explore the potential of using a monoclonal antibody in addressing HD. Patients enrolled in the SIGNAL trial will be treated with an intravenous infusion of VX15 and undergo periodic disease monitoring using brain scanning techniques, MRIs, and PETs.
“This is a great opportunity for patients in early stages of Huntington’s to be involved in a study that may slow the progression of the disease,” LaFaver said. “The drug was already tested for safety in patients with multiple sclerosis and was well tolerated.”
The SIGNAL trial is open to willing participants who are:
- At risk for developing HD
- Have undergone genetic testing
- Thought to be in the early stage of HD
- Able to undergo brain scans (MRI and PET)
- At least 21 years of age
Enrolment for SIGNAL is now open and will run through the second half of 2016. The study’s participants will be treated for a span of 12 months and must comply with an additional follow up period of 3 months. Aside from treatment with VX15, participants will receive HD-related medical care and testing, and reimbursement for in-person visits and any accrued travel/lodging costs.
To learn more about SIGNAL and how one can participate, contact Annette Robinson, RN, BSN, CCRC at 502-540-3585, [email protected]
Individuals also may contact the Huntington Study Group at 1-800-487-7671, email [email protected] or http://www.huntington-study-group.org.