MINERAL (Magnetic-resonance Image of Nutraceutical Efficacy on Relapsi

Novel oral nutraceutical intervention NEUROASPIS PLP10® for the treatment of relapsing-remitting multiple sclerosis: A multicenter, parallel-group, phase III, double-blind, randomized, placebo-controlled, add-on with Interferon Beta, trial of efficacy and safety

Completed (inferred)Phase 3Relapsing MSISRCTN06166891

What it measured

Main measures

  • Primary outcome measures as of 31/03/2016: At 2 years the primary end points will be the annual relapse rate (ARR) 1. The study is designed to end 30 months after enrollment (plus 12-month washout period) and neurological and clinical assessments should be scheduled at entry baseline (6 months after enrollment, the end of normalization period) and at 6, 12, 18 and 24 months on-treatment. Another

    Disability progressionRelapsesMRI lesionsBrain volume lossMyelin repairSafety

Other measures (1)

  • Secondary end points at 2 years will be the time to confirmed disability progression and quantity changes of inflammatory/anti-inflammatory markers in the blood Time to confirmed disability progression is defined as an increase of 1.0 on the EDSS from a baseline score of 1.0 or more or an increase of 1.5 or more from a baseline score of 0.0, confirmed after 6 months, with an absence of an ongoin

    Disability progressionRelapsesMRI lesionsBrain volume lossMyelin repairImmune responseHow the body handles the medicineSafety

Papers

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History

  1. In scope changed from true to false

  1. Started

    Feb 2016

  2. Finished

    Dec 2018

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