Clinical Report: ALS Trial Tests Celecoxib–Ciprofloxacin Combination
Overview
The phase 2b PARADIGM trial evaluated the fixed-dose combination of celecoxib and ciprofloxacin (PrimeC) in ALS patients, demonstrating a safety profile comparable to placebo and a numerically slower decline in ALSFRS-R scores. These findings support further investigation of PrimeC as a potential disease-modifying therapy.
Background
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with limited treatment options. Current therapies primarily focus on symptom management rather than modifying disease progression. The exploration of new combinations, such as PrimeC, could provide insights into potential disease-modifying therapies for ALS patients.
Data Highlights
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{'add': 'Mention the statistical analysis methods used.'}Clinical Implications
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Conclusion
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References
- Cudkowicz MC, et al., JAMA Neurology, 2023 -- Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis: The PARADIGM Randomized Clinical Trial
- European Academy of Neurology (EAN) guideline on the management of amyotrophic lateral sclerosis, PMC, 2024
- Evaluating Cardiovascular Risks Associated with Non-steroidal Anti-inflammatory Medications: Implications for Clinical Practice, Springer, 2014
- No Evidence of Celecoxib Benefit Reported in Patients With Early Breast Cancer, The ASCO Post, 2018
- New Research Explores Blood Test to Determine Prognosis, Benefit of Celecoxib in Stage III Colon Cancer, The ASCO Post, 2025
- The ASCO Post — Actively Recruiting Clinical Trials Focused on Novel Drug Combinations for Gallbladder and Biliary Tract Cancers
- European Academy of Neurology (EAN) guideline on the management of amyotrophic lateral sclerosis in collaboration with European Reference Network for Neuromuscular Diseases (ERN EURO‐NMD) - PMC
- Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis: The PARADIGM Randomized Clinical Trial | Trials | JAMA Neurology | JAMA Network
- Trial of celecoxib in amyotrophic lateral sclerosis - PubMed
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