Stopped earlyRelapsing and progressiveNCT04948606

What it found

Stopped early

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

Reason given: Sponsor Decision

This trial finished 3 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

  • Percentage of Participants on Treatment with DRF

    Year 1

Other measures (16)

  • Percentage of Participants on Treatment with DRF

    Month 3

  • Percentage of Participants on Treatment with DRF

    Year 2

  • Annualized Relapse Rate (ARR) with DRF

    Year 1 and 2

    Relapses
  • Percentage of Participants Relapsed

    Year 1 and 2

    Relapses
  • Change in Cognitive Processing Speed Test (CPST) Score

    Baseline, Year 1 and 2

    Thinking and memory
  • Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire

    Baseline, Year 1 and 2

    Quality of life (reported by participants)
  • Change in Disability, as Measured by Expanded Disability Status Scale (EDSS)

    Baseline, Year 1 and 2

    Disability progression
  • Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Score

    Baseline, Year 1 and 2

    Quality of life (reported by participants)Safety
  • Number of Participants with Gastrointestinal (GI) Adverse Events (AEs)

    Up to Month 32

    Safety
  • Number of Participants with AEs Leading to Treatment Discontinuation

    Up to Month 32

Who could take part

Relapsing and progressive · 18 and over

Key Inclusion Criteria: * Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information. * DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose. Key Exclusion Criteria: * History of gastric bypass or required use of feeding tubes. * Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen * Have received prior treatment with DRF (more than 7 days before enrollment). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

About this trial

In the sponsor's words

The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs].

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History

    1. Started

      Dec 2021

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

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