Researchers are looking for people with ALS (amyotrophic lateral sclerosis) to participate in the CENTAUR ALS clinical trial. Sponsored by Amylyx Pharmaceuticals, the phase 2 trial is designed to test the safety and tolerability of the experimental drug AMX0035 and determine whether the treatment is able to slow decline of function in people with ALS.
AMX0035 is a combination therapy, designed to block key cellular death pathways and, in turn, reduce nerve cell death and inflammation to slow the progression of ALS.
Trial length is approximately 28 weeks, during which participants will visit with study investigators seven times in person and four times via phone. At in-person visits, participants will undergo strength testing, blood draws and other assessments to enable investigators to determine whether AMX0035 has any effects on muscle strength and respiratory function, as well as help them determine whether biomarkers that can signal nerve cell death are present.
In order to be eligible to participate, individuals must be at 18-80 years old, have a definite diagnosis of ALS as defined by the World Federation of Neurology revised El Escorial criteria, be at less than or equal to 18 months since ALS symptom onset and meet other eligibility criteria.
The trial is taking place at 25 trial sites across the United States.
To learn more about this trial, visit clinicaltrials.gov and enter NCT03127514 into the search box. Scroll down to the “Contacts and Locations” section of the page to view contact information for active trial sites.