Study Title: A low molecular weight dextran sulphate, ILB, for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial
Summary
Amyotrophic lateral sclerosis (ALS) is a severe neurological condition with no cure. This study investigated the safety and tolerability of ILB® in ALS patients. The trial showed that long-term weekly ILB® injections of 2 mg/kg were well tolerated and had an acceptable safety profile in patients with ALS.
Key Findings
– 11 patients were treated for up to 38 weeks with no treatment terminations or withdrawals.
– One serious adverse event was reported, not related to ILB®.
– 270 mild/moderate adverse events were reported with no intolerable events occurring during the trial.
– Total number of ILB® treatments administered per patient ranged from 4 to 38, with a cumulative dose ranging from 745 to 6668 mg.
– Three patients died after the trial was halted, between 53 and 62 weeks after their final ILB® injection.
Value and Solutions
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