CLINICAL STUDIES

The Clinical Study

The Clinical Study: “A novel oral nutraceutical formula of omega-3 and omega-6 fatty acids with vitamins (PLP10) in relapsing remitting multiple sclerosis: a randomised, double-blind, placebo-controlled proof-of-concept clinical trial” was performed from July 2007 until December 2010, according to the global standards of clinical research for the disease and with the participation of 80 patients with relapsing multiple sclerosis. The study design and the medical protocol included many innovations leading to the preparation of the formulation. Unlike anything else available, this formulation (with the code PLP10) is a nutraceutical (with natural biomolecules), administered orally, can be co-administered with all other available treatments, showed great therapeutic effect in reducing the frequency of relapses (flares) of the disease but mainly on the progression of the disability of patients. Moreover, it is potentially able to trigger remyelination, neuroprotection and mainly free of side effects.

Due to the multiple ingredients consisting the formulation has the ability to influence a holistic treatment of the disease and is able to affect the total known biological and biochemical network of pathogenic/pathogenetic events and mechanisms that cause the disease, including the biochemical mechanisms responsible for remyelination and restoration of neurons (healing). In more detail, the formulation by the code PLP10, versus placebo showed significant healing abilities for the sample of patients in the study, reducing the frequency of relapses of the disease up to 72% and the possibility of disability progression up to 86% without any severe side effects. The formulation itself, as well as the new therapeutic philosophy of holistic approach to the disease by systems medicine through systems Biology is a formidable light-beam for persons suffering with this incurable chronic disease and not only. There are multiple scientific evidence for use of the formulation for other neurodegenerative diseases such as Parkinson’s, Alzheimer’s etc. Finally, the profile and safety of the intervention/formulation PLP10 makes it engaging enough for usage as a prevention food supplement formula for diseases of the central nervous system in general, and more specifically for patients with the Clinically Isolated Syndrome (CIS), i.e. with the first stroke of MS or even for chronic neurodegenerative diseases such as Alzheimer’s disease, the greatest scourge of mankind today.

Today

Currently, there is an ongoing registered Phase III: ISRCTN06166891 DOI 10.1186/ISRCTN06166891; the MINERAL (Magnetic-resonance Image of Nutraceutical Efficacy on Relapsing-ms Autoimmune Lesions) study: a novel nutraceutical formula PLP10 for the treatment of relapsing-remitting multiple sclerosis. This is a multi-center double-blind placebo controlled study with three clinical sites in Greece and one in Cyprus, with 220 patients enrolled.