SUPREMES - Sunphenon in progressive forms of multiple sclerosis

CompletedPhase 2Phase 3Progressive MS2008-005213-22

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Sunphenon

What it measured

Main measures

  • Brain Parenchymal Fraction / atrophy after 36 months of treatment vs. placebo

    Brain volume loss

Other measures (1)

  • T2 leasion, T1 hypotensive leasion, EDSS, changes in NAA/Cr quotient in spectroscopy, cognitive disorders and fatigue

    Disability progressionMRI lesionsThinking and memoryFatigue

Who could take part

Progressive MS · EDSS 3 to 8

Show the full criteria

Inclusion criteria

Inclusion: age 18-65, primary or secondary progressive Multiple Sclerosis according to McDonald-criteria, EDSS 3-8, negative pregnancy test, use of highly effective methods of birth control in women with childbearing potential, informed consent, max. 4 cups of coffee and 2 cups of black tea daily, no consumption of grean tea or larger amounts of grapefruit juice, at least 30 days between the last relapse and screening Exclusion: relapsing remitting Multiple Sclerosis, clinical or laboratory findings of impaired liver function, psychiatric disorders, concomitant medication of hepatotoxic medication, any other relevant disorder

Exclusion criteria

Not separately supplied in the registry.

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

About this trial

In the sponsor's words

To evaluate efficacy and safety of Sunphenon EGCg in progressive forms of multiple sclerosis after a 36 months treatment compared to the placebo-group, primary outcome criteria being reduction of Brain Parenchymal Fraction (atrophy)

Papers

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History

    1. Started

      Aug 2008

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