A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.

Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G.

of Experimental Neurology (INSPE) and Department of Neurology, San
Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy;
Fondazione Don Carlo Gnocchi, IRCCS, Milan, Italy.

A sixth month
phase II multicenter-pilot trial with a low dose of the opiate
antagonist Naltrexone (LDN) has been carried out in 40 patients with
primary progressive multiple sclerosis (PPMS). The primary end points
were safety and tolerability. Secondary outcomes were efficacy on
spasticity, pain, fatigue, depression, and quality of life. Clinical
and biochemical evaluations were serially performed. Protein
concentration of beta-endorphins (BE) and mRNA levels and allelic
variants of the mu-opiod receptor gene (OPRM1) were analyzed. Five
dropouts and two major adverse events occurred. The remaining adverse
events did not interfere with daily living. Neurological disability
progressed in only one patient. A significant reduction of spasticity
was measured at the end of the trial. BE concentration increased during
the trial, but no association was found between OPRM1 variants and
improvement of spasticity. Our data clearly indicate that LDN is safe
and well tolerated in patients with PPMS.

PMID: 18728058 [PubMed – in process]

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