update on ldn trials
linical Trials of LDN in Planning Stages
> University of California, San Francisco — MS Trial
Pending institutional approval, the year 2007 may finally see a US clinical study of LDN in multiple sclerosis. A crossover study at the University of California, San Francisco, is being planned by neurological researcher Bruce Cree, MD. If approved, some 80 patients with MS will be involved. Contributions would surely be welcome and can be made by contacting the Clinical Studies Manager at UCSF, Dr. Elena Koryeyeva, at 415-514-2467.
> Stanford University School of Medicine — Fibromyalgia Study
A post-doctoral scholar at the Department of Anesthesia in the Stanford Neuroimaging and Pain Lab is planning a clinical study on LDN for fibromyalgia in 2007.
> Bamako University Hospital, Mali, Western Africa — HIV Trial
Jaquelyn McCandless, M.D., the neurologist who is the U.S. Medical Consultant/Coordinator for the Mali LDN HIV+ Study, visited Mali in December 2006 and met with the clinical study team at Bamako University Hospital as well as the head of the Malian Ethics Committee. She was highly impressed with the university’s research facility, and reports that “everyone we have met so far is very friendly, helpful, and highly interested in the success of this program.” For further details of her report, please see the linked Developing Nations Project page.
The planned Mali study will involve three groups of 50 volunteers each, all of whom are HIV positive and each of whom has a CD4 cell count in the range of 275 to 475. One group will receive LDN only, one will be treated with LDN and antiretroviral drugs, and the third group will receive ARV’s only. The length of the planned study is 48 weeks. The hope is to implement it when funding is completed. Dr. McCandless is actively seeking philanthropic donations (e-mail her here).
Clinical Trials of LDN in Progress
> Multi-Institutional Clinical Trial of LDN for MS Has Begun in Italy
A long-awaited pilot study of low dose naltrexone therapy in multiple sclerosis has been implemented by the Milan neurological researcher, Dr. Maira Gironi. Several northern Italian hospitals began enrolling patients for the study during the first week of December, 2006. Dr. Gironi anticipates that the 6 months of LDN treatment will have been completed by early summer. Importantly, Dr. Gironi’s research team has long been a locus for significant research on endorphins in relation to illness, and this study will track accurate assessments of the patients’ beta-endorphin levels in response to their LDN treatment.
> Penn State Phase II Trial of LDN Therapy for Crohn’s Disease
Dr. Jill Smith, Professor of Gastroenterology at Pennsylvania State University’s College of Medicine, began registering patients for this Phase II study in September 2006. It is the first Phase II clinical trial of LDN at a US medical center, and will examine LDN’s efficacy in the treatment of people with Crohn’s Disease. Below are brief extracts from the Penn State trial website:
Study Protocol Participants will have a complete physical, blood work taken, keep symptom diaries, complete questionnaires and continue with follow-up for 4 months.
Cost of medication, office visits, and blood work are paid by the study. This research has been approved by the Institutional Review Board, under FDA regulations, at Penn State’s College of Medicine. Interested patients contact Sandra Bingaman, R.N. at 717-531-8108.
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