Exploring new treatments through clinical trials
Prime C, a combination of ciprofloxacin and celecoxib, is moving to the 48-week PARAGON phase 3 trial after reported phase 2 and open-label extension results. The organisation’s report says the 12-month open-label study found a 33% slowing in functional decline, with an improvement in speech and swallowing also noted.
Why this matters
PARAGON is planned to involve about 300 people with motor neurone disease in the US, Europe and Israel. It will test whether Prime C slows functional decline measured by the ALS Functional Rating Scale–Revised. These findings come from an organisation’s report of a symposium presentation and do not establish that Prime C works or change treatment now.
Limitations and context
The source is an organisational blog reporting a symposium presentation, not a peer-reviewed primary research paper. The reported 33% result comes from an open-label extension, in which everyone received the drug, so it cannot by itself provide a controlled comparison. The larger phase 3 trial is intended to test the treatment more rigorously; its results are not yet available.