Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizu

Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizumab

WithdrawnNot a drug-phase studyRelapsing and progressiveNCT05172466

What it found

Stopped

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

Reason given: Lack on enrollment

What was tested

Treatment tested

  • BeCare application

What it measured

Main measures

  • The Expanded Disability Status Scale (EDSS)

    Week 0 to 4

    Disability progressionVisionThinking and memoryWalking and mobilityPhysical functionBladder, bowel and sexual function

  • The Expanded Disability Status Scale (EDSS)

    Week 1-6

    Disability progressionVisionThinking and memoryWalking and mobilityPhysical functionBladder, bowel and sexual function

  • The Expanded Disability Status Scale (EDSS)

    Week 12-18

    Disability progressionVisionThinking and memoryWalking and mobilityPhysical functionBladder, bowel and sexual function

  • The Expanded Disability Status Scale (EDSS)

    Week 24-32

    Disability progressionVisionThinking and memoryWalking and mobilityPhysical functionBladder, bowel and sexual function

Other measures (76)

  • Application Based - Timed Up and Go (TUG)

    Week 0 to 4

    Walking and mobility

  • Application Based - Timed Up and Go (TUG)

    Week 1-6

    Walking and mobility

  • Application Based - Timed Up and Go (TUG)

    Week 12-18

    Walking and mobility

  • Application Based - Timed Up and Go (TUG)

    Week 24-32

    Walking and mobility

  • Application Based - Tap Task

    Week 0 to 4

    Fatigue

  • Application Based - Tap Task

    Week 1-6

    Fatigue

  • Application Based - Tap Task

    Week 12-18

    Fatigue

  • Application Based - Tap Task

    Week 24-32

    Fatigue

  • Application Based - Path Test

    Week 0 to 4

  • Application Based - Path Test

    Week 1-6

Who could take part

Relapsing and progressive · 18 to 60

Show the full criteria

Inclusion criteria

* Clinical diagnosis: RRMS (relapsing-remitting MS) or Multiple Sclerosis (Clinically Isolated Syndrome [CIS], Primary Progressive [PPMS], Secondary Progressive [SPMS) * Prescribed Tysabri (Natalizumab) or any other MS medication * Natalizumab/Tysabri-naïve * Ages 18-60 * Access to a smartphone* *In case a participant is ineligible due to lack of access to the technology, the study team will loan a tablet to participants for the duration of the study, free of charge. Participants will not be responsible for losing or damaging the device.

Exclusion criteria

* Inability to perform 5 or more of the BeCare App tasks independently * EDSS >6.5 * Corrective Visual Acuity lower than 20/200 * Any chronic illness that has not been stable for at least six months (medication changes during the past year for that condition are not exclusionary) * Malignancy/previous chemotherapy treatment for neoplastic disease * Untreated or unstable major depression or bipolar disease * Clinical diagnosis: SPMS (Secondary-progressive multiple sclerosis) or PPMS (primary-progressive MS) 8. Acute COVID-19 infection with persisting symptoms for the last 6 weeks

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

About this trial

In the sponsor's words

The goal of this proposal is to use the BeCare App to (1) determine changes in "Feel Good Effect", or "Restoring Physiologic Homeostasis(RPH)"for individuals with relapsing-remitting MS (RRMS) before and after starting Natalizumab therapy and (2) Compare BeCare-derived with clinically-derived performance metrics.

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History

    1. Started

      Oct 2022

    2. Main results due

      Nov 2022

    3. Finished

      Nov 2022

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