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A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05988073
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
argenx

Study Description
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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
Multifocal Motor Neuropathy

Study Design
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Study Type : Observational
Estimated 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
Actual Study Start Date : November 29, 2023
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To characterize MMN patient profiles for participants [ Time Frame: up to 24 months ]
  2. To assess the MMN disease management and disease course [ Time Frame: up to 24 months ]
  3. To assess outcome measures specific to MMN disease and their evolution over time [ Time Frame: up to 24 months ]
  4. To estimate the burden of MMN on participants' quality of life [ Time Frame: up to 24 months ]
  5. To estimate the economic burden for participants with MMN [ Time Frame: up to 24 months ]
  6. To collect data on relevant disease biomarkers [ Time Frame: up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with MMN receiving standard of care at their treating physician.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05988073


Contacts
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Contact: Sabine Coppieters, MD 857-350-4834 ClinicalTrials@argenx.com

Locations
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Sponsors and Collaborators
argenx
More Information
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Responsible Party: argenx
ClinicalTrials.gov Identifier: NCT05988073    
Other Study ID Numbers: ARGX-117-2202
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases