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.
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Original Article
Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis†
Article first published online: 19 FEB 2010
DOI: 10.1002/ana.22006
Copyright © 2010 American Neurological Association
Additional Information
How to Cite
Cree, B. A. C., Kornyeyeva, E. and Goodin, D. S. (2010), Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol., 68: 145–150. doi: 10.1002/ana.22006
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Publication History
- Issue published online: 2 AUG 2010
- Article first published online: 19 FEB 2010
- Manuscript Accepted: 10 FEB 2010
- Manuscript Revised: 8 JAN 2010
- Manuscript Received: 2 JUL 2009
Funded by
- Sammy Jo Wilkinson of ldners.org
- Fundraisers through an unrestricted gift to the UCSF MS Center
- Abstract
- Article
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- Cited By
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. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non–MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. 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. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05).
Interpretation
LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010