Stopped earlyPhase 4Relapsing and progressiveNCT02901106

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Another surveillance protocol was initiated by the OFSEP (OFSEP cohort) which allows to follow all the patients, whatever their treatment.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Number of patients with a relapse and/or progressive worsening of disease (EDSS score)

    After one year of treatment

    Disability progressionRelapses

Who could take part

Relapsing and progressive · 18 and over

Inclusion Criteria: * patient 18 years old and more * with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP) * for which treatment with dimethyl-fumarate has been prescribed * followed at the Rothschild Foundation in the Neurology Department * having given written consent to participation in the study Exclusion Criteria: * pregnant or breastfeeding woman * patient with a measure of legal protection * subject unaffiliated insurance

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

About this trial

In the sponsor's words

The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS. Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease. It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment. The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.

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History

    1. Started

      May 2017

    2. Main results due

      Oct 2017

    3. Finished

      Oct 2017

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