L-ACETYLCARNITINE IN THE TREATMENT OF PATIENTS WITH PERIPHERAL NEUROPATHIES - A SHORT-TERM, DOUBLE-BLIND CLINICAL-STUDY OF 426 PATIENTS

426 patients with peripheral motor or sensory neuropathies were recrui ted and randomly assigned to 2 treatment groups in a double-blind, 30- day, prospective trial comparing L-acetylcarnitine (LAC) [1000 mg/day intramuscularly for the first 10 days then 2000 mg/day orally for the remaining 20 days] with placebo. Treatment efficacy was assessed by co mmonly employed electrophysiologic al tests performed at baseline and at the end of treatment. Safety and tolerability evaluations were perf ormed on the entire patient. population, although the statistical anal ysis for efficacy was restricted to the 298 patients with lower-than-n ormal nerve conduction velocities (CVs) at baseline. Among patients wi th impaired motor nerve function, a statistically significant improvem ent in mean CV (p < 0.01 vs placebo) was detected in LAC-treated indiv iduals with mononeuropathies, whereas no statistical difference emerge d between the LAC-and placebo-treated groups in patients with motor ne rve polyneuropathies. In contrast, there were statistically significan t differences between the LAC and placebo groups in terms of improveme nt in mean CV in patients with sensory nerve mononeuropathies (p < 0.0 5) and in those with sensory nerve polyneuropathies (p < 0.05). Only 1 7 patients reported poor tolerability to treatment, and only 7 of the 32 patients who were withdrawn from the study did so because of advers e events. Our trial demonstrated the efficacy of LAC in improving elec trophysiological nerve conduction properties in patients with sensory or motor neuropathies.