PLOS ONE · 9 authors, 7 centres
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This preclinical study in purpose-bred hound dogs evaluated the safety, tolerability, and pharmacokinetics of continuous intrathecal (IT) riluzole infusion alone and combined with oral dosing across non-GLP and GLP studies. IT infusion increased spinal cord riluzole concentrations above those achieved with oral administration alone, without elevating liver enzymes or substantially raising brain concentrations at tolerable doses.
Dogs were randomized to IT saline, IT vehicle, oral riluzole 50 mg BID alone, or oral plus IT riluzole at escalating doses. In the 6-week study, the highest IT dose (0.2 mg/hr) was well tolerated and increased spinal cord concentrations above oral-only levels without increasing brain concentrations. In the 6-month study, the highest dose (0.4 mg/hr) was not tolerated. IT infusion did not increase liver enzyme levels across studies.
