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A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy

Sponsor
argenx (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05988073
Collaborator
(none)
150
Enrollment
25
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter Prospective Longitudinal Study of Clinical Outcomes, Disease Course, Health-Related Quality of Life, and Health Care Resource Utilization in Adult Patients With Multifocal Motor Neuropathy
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2025
    Anticipated Study Completion Date :
    Nov 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. To characterize MMN patient profiles for participants [up to 24 months]

    2. To assess the MMN disease management and disease course [up to 24 months]

    3. To assess outcome measures specific to MMN disease and their evolution over time [up to 24 months]

    4. To estimate the burden of MMN on participants' quality of life [up to 24 months]

    5. To estimate the economic burden for participants with MMN [up to 24 months]

    6. To collect data on relevant disease biomarkers [up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Is at least the local legal age of consent for clinical studies when signing the ICF

    • Is capable of providing signed informed consent and complying with protocol requirements

    • Has an existing or new diagnosis of MMN made by a neuromuscular specialist or neurologist

    Exclusion Criteria:

    • Is currently participating in any clinical study with an IMP

    • Has other medical conditions that could affect the assessment of MMN

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • argenx

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    argenx
    ClinicalTrials.gov Identifier:
    NCT05988073
    Other Study ID Numbers:
    • ARGX-117-2202
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuritis

    Study Results

    No Results Posted as of Aug 14, 2023