Stopped earlyRelapsing MSNCT05701423

What it found

Stopped early

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

Reason given: Due to low enrolment the sponsor decided to terminate the study

What was tested

Treatment tested

  • Natalizumab

    Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

What it measured

Main measures

  • Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ

    Up to 30 weeks

Other measures (6)

  • Change From Baseline in Expanded Disability Status Scale (EDSS) Score

    Baseline up to 30 weeks

    Disability progression
  • Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Baseline up to 30 weeks

    Thinking and memoryFatigue
  • Change From Baseline in Fatigue Severity Scale (FSS)

    Baseline up to 30 weeks

    Fatigue
  • Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score

    Baseline up to 30 weeks

    Quality of life (reported by participants)
  • Change From Baseline in Brief Fatigue Inventory (BFI) Score

    Baseline up to 30 weeks

    Fatigue
  • Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score

    Baseline up to 30 weeks

    Disability progressionWalking and mobility

Who could take part

Relapsing MS · 18 and over

Key Inclusion Criteria: * Diagnosed Relapsing-Remitting Multiple Sclerosis (RRMS) according to 2017 revised McDonald criteria * Initiation of treatment with SC NTZ according to summary of product characteristic (SmPC) and in accordance to national guidelines or * Continuing treatment with IV NTZ * Owns and be able to handle a smartphone Key Exclusion Criteria: * Participants with an acute MS relapse and/or a history of intravenous corticosteroid treatment within past six weeks * Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia * Diagnosis of primary or secondary progressive MS * Additional immunosuppression except of natalizumab 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 this study is to better understand the pathophysiological background of end-of-dose symptoms (EOD) and thereby determine the percentage of participants who develop EOD under natalizumab (NTZ) as an example of interval therapy in MS and to detect specific changes through multimodal analyses, including radiological, blood and digital health measurements, that may be used as potential biomarkers in the future to map EOD.

Papers

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Related trials

History

    1. Started

      Feb 2023

    2. Main results due

      Jul 2024

    3. Finished

      Jul 2024

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