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The PARADIGM trial evaluated PrimeC, an oral combination of celecoxib and ciprofloxacin designed to target neuroinflammation, iron regulation and disease-associated microRNAs in amyotrophic lateral sclerosis (ALS). Sixty-nine participants were randomized 2:1 to PrimeC or placebo for six months, followed by a 12-month open-label extension. During the blinded phase, the between-group difference in the ALS Functional Rating Scale–Revised (ALSFRS-R) was 2.23 points (95% CI, −0.61 to 5.07; \(p=0.12\)), which was not statistically significant. At month 18, participants continuously treated with PrimeC had a 7.92-point difference in ALSFRS-R scores (95% CI, 2.25–13.60; \(p=0.007\)); however, these extension findings require cautious interpretation because the placebo-controlled comparison was no longer maintained. Overall adverse-event rates were similar between groups. The investigators concluded that PrimeC was generally well tolerated and that the clinical and biomarker findings justify a larger confirmatory trial, rather than establish efficacy.
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The PARADIGM trial evaluated PrimeC, an oral combination of celecoxib and ciprofloxacin designed to target neuroinflammation, iron regulation and disease-associated microRNAs in amyotrophic lateral sclerosis (ALS). Sixty-nine participants were randomized 2:1 to PrimeC or placebo for six months, followed by a 12-month open-label extension. During the blinded phase, the between-group difference in the ALS Functional Rating Scale–Revised (ALSFRS-R) was 2.23 points (95% CI, −0.61 to 5.07; \(p=0.12\)), which was not statistically significant. At month 18, participants continuously treated with PrimeC had a 7.92-point difference in ALSFRS-R scores (95% CI, 2.25–13.60; \(p=0.007\)); however, these extension findings require cautious interpretation because the placebo-controlled comparison was no longer maintained. Overall adverse-event rates were similar between groups. The investigators concluded that PrimeC was generally well tolerated and that the clinical and biomarker findings justify a larger confirmatory trial, rather than establish efficacy.
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