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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05988073




Registration number
NCT05988073
Ethics application status
Date submitted
4/08/2023
Date registered
14/08/2023

Titles & IDs
Public title
A Prospective Longitudinal Study in Adults with Multifocal Motor Neuropathy
Scientific 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
Secondary ID [1] 0 0
ARGX-117-2202
Universal Trial Number (UTN)
Trial acronym
iMMersioN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multifocal Motor Neuropathy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To characterize MMN patient profiles for participants
Timepoint [1] 0 0
up to 24 months
Primary outcome [2] 0 0
To assess the MMN disease management and disease course
Timepoint [2] 0 0
up to 24 months
Primary outcome [3] 0 0
To assess outcome measures specific to MMN disease and their evolution over time
Timepoint [3] 0 0
up to 24 months
Primary outcome [4] 0 0
To estimate the burden of MMN on participants' quality of life
Timepoint [4] 0 0
up to 24 months
Primary outcome [5] 0 0
To estimate the economic burden for participants with MMN
Timepoint [5] 0 0
up to 24 months
Primary outcome [6] 0 0
To collect data on relevant disease biomarkers
Timepoint [6] 0 0
up to 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is currently participating in any clinical study with an IMP
* Has other medical conditions that could affect the assessment of MMN

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Kansas
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Texas
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Edegem
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Gent
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Jette
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Leuven
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Belgium
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Liege
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Pleven
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Sofia
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Nanchang
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China
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Sheffield
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Taunton
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
argenx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabine Coppieters, MD
Address 0 0
Country 0 0
Phone 0 0
857-350-4834
Fax 0 0
Email 0 0
ClinicalTrials@argenx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05988073