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PatientsLikeMe launches 'virtual trial' in ALS

Partners with The Duke ALS Clinic on study of the Soy Peptide Lunasin

Virtual trial pharma PatientsLikeMe

PatientsLikeMe has started a small-scale 'virtual trial' to evaluate the potential of a peptide to reverse the symptoms of degenerative motor disorder ALS.

The online community is working with The Duke ALS Clinical in the US on the study, which will involve 50 patients with amyotrophic lateral sclerosis, known as motor neurone disease or Lou Gehrig's Disease.

The trial will test whether Lunasin, a peptide found in soy and some cereal grains, can help reverse ALS, following a review that found it might have beneficial effects. It's a particularly apt programme to be taken on by PatientsLikeMe as when the community was set up in 2005 it was initially as a website for ALS patients to share their experiences.

The Lunasin Virtual Trial (or, virtually virtual trial) is the first study of the supplement in ALS patients, and will see participants make three in-person visits to the Duke ALS clinic to measure the supplement's impact over the course of the year-long study.

They will also complete virtual check-ins as members of PatientsLikeMe every 30 days to update their weight and complete an evaluation of their Lunasin regimen as well as completing the ALS Functional Rating Scale, a patient-reported outcome tool. 

The trial's protocol has been published on Duke's ALS Reversals website and Duke ALS clinic director Richard Bedlack said that, in addition to its open approach, the work aims to eliminate many of the frustrations patients say are inherent in traditional clinical trials.

“There are no placebos, and we made the inclusion criteria very broad so that even ALS patients who can't qualify for other studies due to their long disease duration or use of a ventilator can qualify,” he said.

Attempts to pursue virtual trials within pharma have had mixed success to date, with Pfizer's pioneering efforts in managing study participation electronically ultimately abandoned in 2012. More recently, however, a Sanofi-backed consortium said in June this year that its VERKKO remote online phase IV clinical trial in diabetes had been a success.


11th November 2016

From: Research



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