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
A Phase I Study of DNL343 sponsored by Denali Therapeutics: NOW ENROLLING
This first-in-human study is investigating the safety of DNLI343, an orally-administered capsule, for treatment of ALS. Subjects will be randomized 1:1:1 to receive one of 2 dose levels of active drug or a placebo. Length of participation is approximately 2 months, with an open-label extension of 18 months. If you have disease onset of fewer than 3 years, are 18 years or older, and are able to swallow capsules you may be eligible. Please contact Wanda Sanchez via email to learn more.
Biogen Ataxin Study: NOT ENROLLING
This is a first-in-human gene therapy trial for sporadic ALS to evaluate the safety of BIIB-105. There will be 6 cohorts, with subjects being randomized 3:1 to receive active drug or placebo. Five doses of drug will be administered via lumbar puncture over 12 weeks, with total participation period to be approximately 29 weeks. For more information, please contact Annie Rowland via email.
Mitsubishi Oral Drug Dosing Regimen Study: NOW ENROLLING
The purpose of this study is to test if an oral formulation of the FDA-approved IV drug edaravone (Radicava) is effective and safe in patients with ALS, and to compare its effects when given in 2 different dose regimens. Subjects will be randomized 1:1 to either Group 1 which will receive active drug daily for 14 days, followed by 2 weeks off drug, or Group 2 which will receive edaravone to be taken daily in 28-day on/off cycles. For more information, please contact Virginia James by email.