Researchers led by Richard Bedlack from Duke University’s ALS Clinic in Durham, North Carolina, and the patient network PatientsLikeMe (PLM) have launched an innovative clinical trial to test efficacy of the peptide supplement Lunasin in ALS. The trial was motivated by the surprising case of an ALS patient who reported reversal of his symptoms while taking the supplement (see ALSUntangled report). The partners at Duke and PLM set out to systematically test its effect in a way that would be both inexpensive and attractive for patient recruitment. To this end, they designed a unique Phase II clinical trial that relies on patient reported outcomes and data from historical controls for the placebo arm. In addition, they publicized the protocol to enable patients outside the trial to report their outcomes.
Read more about this unique clinical trial here.