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First LDN Clinical Trial in MS Study Published

By Elaine Moore on 9/19/2008

Dr. Maira Gironi and her colleagues in Milan Italy have published the results of their phase II clinical trial of low dose naltrexone (LDN) in the September issue of the journal Multiple Sclerosis. The study involved 40 patients with primary progressive multiple sclerosis (PPMS) evaluated over a period of 6 months. In April 2008 Dr. Gironi presented the preliminary results of this study at the annual MS Conference in Chicago. 



PPMS is a severe form of MS characterized by an absence of the remissions seen in remitting relapsing forms of MS.  Dr. Gironi’s study primarily assessed the safety and tolerability of LDN in patients with PPMS.  Although the study didn’t focus on efficacy, improvement in symptoms was evaluated. LDN was found to be safe and well tolerated. Levels of beta endorphins were also assessed.



LDN was found to markedly reduce spasticity, while pain, fatigue and depression did not significantly improve. The study didn’t evaluate urinary frequency, a common symptom of MS, which has anecdotally been reported to improve with LDN. The conclusion of the study indicated that LDN is clearly safe and well tolerated in patients with PPMS.



Similar to what has been reported in previous studies conducted and published by Dr. Gironi, beta endorphin levels increased with the highest increases seen one month after the cessation of therapy.

Side effects attribued to LDN were mild and included irritability. In two cases, liver enzymes were elevated but this could have been the result of other medications.



At the April MS conference, Dr. Bruce Cree of the University of California San Diego also presented the results of his LDN study involving patients with all types of MS. LDN was shown to significantly reduce pain, and improve general well being. The final results of his study will be published in October 2008.



Resource:

Gironi M, Martinelli-Boneschi F, Sacerdote P, et al. A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis. Mult Scler. 2008 Sep;14(8):1076-83.



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