We found a newly published placebo-controlled clinical trial of NP001 in patients with ALS and elevated CRP (Muscle & Nerve 2022;epub ahead of print). Unfortunately this trial failed to show an overall benefit of NP001 on ALS progression. Thus, we change our Trials grade from D to F. The trial did find a possible subgroup of patients aged 45-61 that might have had benefit. This will need to confirmed in a new trial.
Since our review was published, a more definitive trial of NP001 was conducted. This failed to show any benefit in slowing ALS progression. We therefore change our NP001 Trials grade from C to D. We would still like to see additional studies of the WF10 form of sodium chlorite.
Key Information
The NP001 formulation of sodium chlorite acts through a plausible mechanism and preliminary data suggest that it is safe and may slow ALS progression in some PALS. The WF10 formulation of SC appears to act through this same mechanism. Although WF10 is available for off-label use, it is very expensive, may have more side-effects than NP001, and at this time has only scant anecdotal evidence for efficacy in PALS. ALSUntangled supports further carefully monitored studies of NP001 and WF10 in PALS. In contrast, oral sodium chlorite has potentially dangerous and toxic side-effects may hasten disease progression, and is not clearly absorbed from the gut. We do not recommend further use of oral sodium chlorite unless it can at least be shown to be safe and to act on mechanisms in humans that are relevant to ALS.