PARADIGM is a Phase 2b, randomized, double-blind, placebo-controlled study, with an Open Label Extension, in the US, EU and Israel, evaluating the safety, tolerability and efficacy of PrimeC in people living with amyotrophic lateral sclerosis (ALS). PrimeC is a novel formulation with unique doses of 2 active compounds, celecoxib and ciprofloxacin.
PARADIGM will evaluate measures that are critical to people with ALS, including change from baseline in ALSFRS-R, ALS associated biomarkers levels, slow vital capacity (SVC), quality of life, and survival.
69 people living with ALS will be enrolled in the study. All people will be administered the PrimeC drug or placebo (ratio of 2:1, respectively), twice daily, for 6 months. People who complete the 6 months dosing will then enter a 12-month open label extension study, in which all people will receive PrimeC. People will be allowed to receive standard of care or background ALS treatments. All assessments will be performed during clinic visits throughout the course of the trial.