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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 : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
argenx

Tracking Information
First Submitted Date August 4, 2023
First Posted Date August 14, 2023
Last Update Posted Date May 14, 2024
Actual Study Start Date November 29, 2023
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2023)
  • To characterize MMN patient profiles for participants [ Time Frame: up to 24 months ]
  • To assess the MMN disease management and disease course [ Time Frame: up to 24 months ]
  • To assess outcome measures specific to MMN disease and their evolution over time [ Time Frame: up to 24 months ]
  • To estimate the burden of MMN on participants' quality of life [ Time Frame: up to 24 months ]
  • To estimate the economic burden for participants with MMN [ Time Frame: up to 24 months ]
  • To collect data on relevant disease biomarkers [ Time Frame: up to 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with MMN receiving standard of care at their treating physician.
Condition Multifocal Motor Neuropathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 4, 2023)		 150
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2025
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sabine Coppieters, MD 857-350-4834 ClinicalTrials@argenx.com
Listed Location Countries Bulgaria,   China,   Czechia,   France,   Italy,   Japan,   Latvia,   Poland,   Romania,   Serbia,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05988073
Other Study ID Numbers ARGX-117-2202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party argenx
Original Responsible Party Same as current
Current Study Sponsor argenx
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account argenx
Verification Date May 2024