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

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

F Martinelli-Boneschi

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

P Sacerdote

Department of Pharmacology, University of Milan, Milan, Italy

C Solaro

Department of Neurology, ASL 3 genovese, Genoa, Italy

M Zaffaroni

Multiple Sclerosis Study Center, Hospital of Gallarate, Gallarate (VA), Italy

R Cavarretta

Fondazione Don Carlo Gnocchi, IRCCS, Milan, Italy

L Moiola

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

S Bucello

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

M Radaelli

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

V Pilato

Multiple Sclerosis Study Center, Hospital of Gallarate, Gallarate (VA), Italy

ME Rodegher

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

M Cursi

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

S Franchi

Department of Pharmacology, University of Milan, Milan, Italy

V Martinelli

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

R Nemni

Fondazione Don Carlo Gnocchi, IRCCS, Milan, Italy

G Comi

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy

G Martino

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy martino.gianvito{at}hsr.it

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 β-endorphins (BE) and mRNA levels and allelic variants of the µ-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.

Key Words: β-endorphins • efficacy • low-dose naltrexone • opioid receptors • primary progressive multiple sclerosis • safety

Multiple Sclerosis, Vol. 14, No. 8, 1076-1083 (2008)
DOI: 10.1177/1352458508095828


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