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Efficacy and Safety study of NEUROASPIS PLP10® versus placebo

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.
OngoingPhase 3Relapsing MS2015-003147-19ISRCTN06166891

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Fish oil

    Supplement

What it measured

Main measures

  • Annual relapse rate (ARR)

    Relapses

  • 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 (2)

  • 1. Time to confirmed disability progression.

    Disability progression

  • 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

Who could take part

Relapsing MS · 18 and over

Inclusion: • Men and women. Exclusion: • Prior immunosuppressants or monoclonal antibodies therapy (prior or concomitant use of cladribine, mitoxantrone, copaxone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, fingolimod or natalizumab (Tysabri), Tecfidera/BG-12).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS)

Papers

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Related trials

History

  1. Completion date changed from Not recorded to 2018-12-31
  2. Result signal changed from ongoing to publication_linked
  3. Has posted results changed from Not recorded to false

  1. Started

    May 2016

  2. Finished

    Dec 2018

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