Researchers are looking for people to participate in a phase 2 clinical trial, sponsored by Neuraltus Pharmaceuticals, that is designed to test whether the investigational drug NP001 slows progression of signs and symptoms in ALS (amyotrophic lateral sclerosis).
Data from some studies suggests that in people with ALS there are increased levels of inflammatory (activated) macrophages, a type of white blood cell, resulting in the release of factors that damage motor neurons. NP001, a regulator of macrophage activation, is designed to exert its effect by converting these activated inflammatory macrophages back to their normal state.
In the study, which is expected to last approximately seven months, participants will receive treatment with either NP001 or placebo and will be required to visit the study site 23 times over the course of the study.
Study investigators will measure the change from baseline in score on the ALS Functional Rating Scale-Revised, a scale that enables physicians to evaluate an ALS patient’s degree of functional impairment. They also will assess change in pulmonary function, time to tracheotomy, and change in levels of blood inflammatory biomarkers.
Participants must have a diagnosis of ALS with onset of ALS-related weakness less than three years prior to the first dose of study drug, and meet additional criteria.
Trial sites are located in Arizona, California, Florida, Georgia, Kansas, Kentucky, Massachusetts, Minnesota, North Carolina, Ohio, Oregon and Texas. Travel support may be available.
To learn more about this trial, including site locations and complete inclusion and exclusion criteria, visit ClinicalTrials.gov and enter NCT02794857 into the search box, or go to Neuraltus’ trial website. You may also contact study coordinator Frances Faurot at 415-912-1981 or firstname.lastname@example.org.