The trial, initiated in 2007 by a group led by Bruce Cree, MD, PhD, at the University of California, San Francisco, sought to evaluate changes in quality of life for multiple sclerosis patients following treatment with 4.5 mg naltrexone (LDN). Eighty patients were enrolled in the trial, and treatment was administered nightly for eight weeks. Of primary interest was a difference in mean score of the multiple sclerosis quality of life inventory (MSQLI54) between LDN-treated and placebo-treated patients.
According to results published in 2010 in the journal Annals of Neurology, at the end of the trial, sixty patients had completed treatment. Ten patients withdrew before the end of the first trial period, but none withdrew due to a multiple sclerosis-LDN adverse event. In fact, one patient withdrew early due to a perceived benefit of treatment. Results from the other ten patients were not available due to database management errors and incomplete quality of life surveys.
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