Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis
Bruce A. C. Cree, MD, PhD, MCR *, Elena Kornyeyeva, MD, Douglas S. Goodin, MD
Multiple Sclerosis Center at University of California, San Francisco, San Francisco, CA
email: Bruce A. C. Cree (bruce.cree@ucsf.edu)
*Correspondence to Bruce A. C. Cree, Multiple Sclerosis Center at UCSF, 350 Parnassus Ave., Suite 908, San Francisco, CA 94117
The patient sponsors of this study did not participate in the design, conduct, or analysis of the trial and did not help write the manuscript. To our knowledge, this is the first patient funded clinical trial in MS.
Funded by:
Sammy Jo Wilkinson of ldners.org
Fundraisers through an unrestricted gift to the UCSF MS Center
Abstract
Objective
To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients.
Methods
This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients.
Results
Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial.... The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. ..
Interpretation
LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010
http://www3.interscience.wiley.com/j...TRY=1&SRETRY=0