Clinical trials are health-related studies in people that are closely supervised and carefully follow a pre-defined protocol. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may be done to see how a new treatment compares with the standard treatment or to see if a new treatment is safe and effective for a certain condition or disease. Participation in this type of research involves treatment with an experimental treatment or medical device, which may or may not provide a direct benefit to the individual. A clinical trial must be conducted for all new treatments before the FDA will approve the treatment for the public. The Emory ALS Center is actively engaged in research projects involving clinical trials of new medications to slow the progression of ALS.
Clinical Trials Currently Enrolling
Biogen SOD1 study: - Limited Enrollment
The VALOR Study is evaluating the safety and potential efficacy of an investigational drug for people living with ALS caused by a SOD1 gene mutation. All participants will receive either the investigational drug or placebo (inactive drug), and all study related visits and care, at no cost. Assistance with travel, accommodations, and reimbursement for study related expenses may be available. For more information contact Meraida Polak at 404-778-3807
Genentech GDC-0134: - No Longer Enrolling
This is a first-in-human study to examine whether the drug GDC-0134 is safe and tolerable in people with ALS. Subject groups will start at a low dose of drug and subsequent groups will be given higher doses of drug if safety of the prior dose is established. There is a placebo group. Participants may only participate in a single dosing period of 28 days, then come in for 2 additional follow-up visits over 1 month. For information contact Jane Bordeau, RN at 404-727-1679
Genentech GDC-0134 Open-Label Extension—No Longer Enrolling
Genentech will be offering an open-label extension of the GDC-0134 study detailed above. This study will be dosing with the same drug, but there will be no placebo group: all participants will receive active drug. The study will require screening and will employ the same eligibility criteria as the main study. The study period will be approximately 12 months, including a 4-week follow-up period. Participants from previous phases of the study are eligible as well as new participants. For further information please contact Jane Bordeau at 404-727-1679
Emory is also Enrolling for a gene therapy study designed to treat patients with mutations in the C9orf72 gene. For more information contact Meraida Polak at 404-778-3807