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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
Date last updated
19/08/2024

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
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
Gold Coast University Hospital - Southport
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Panagyurishte
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Pleven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
China
State/province [13] 0 0
Changsha
Country [14] 0 0
China
State/province [14] 0 0
Nanchang
Country [15] 0 0
China
State/province [15] 0 0
Shangai
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Králové
Country [18] 0 0
Denmark
State/province [18] 0 0
Aarhus
Country [19] 0 0
France
State/province [19] 0 0
Angers
Country [20] 0 0
France
State/province [20] 0 0
Brest
Country [21] 0 0
France
State/province [21] 0 0
Bron
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Limoges
Country [24] 0 0
France
State/province [24] 0 0
Marseille
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France
State/province [25] 0 0
Nantes
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France
State/province [26] 0 0
Nice
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Germany
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Gießen
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Germany
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Potsdam
Country [29] 0 0
Italy
State/province [29] 0 0
Firenze
Country [30] 0 0
Italy
State/province [30] 0 0
Gussago
Country [31] 0 0
Italy
State/province [31] 0 0
Novara
Country [32] 0 0
Italy
State/province [32] 0 0
Palermo
Country [33] 0 0
Italy
State/province [33] 0 0
Pavia
Country [34] 0 0
Italy
State/province [34] 0 0
Pisa
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Japan
State/province [36] 0 0
Mibu
Country [37] 0 0
Latvia
State/province [37] 0 0
Riga
Country [38] 0 0
Poland
State/province [38] 0 0
Bydgoszcz
Country [39] 0 0
Poland
State/province [39] 0 0
Katowice
Country [40] 0 0
Poland
State/province [40] 0 0
Kraków
Country [41] 0 0
Poland
State/province [41] 0 0
Lublin
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Romania
State/province [43] 0 0
Constanta
Country [44] 0 0
Serbia
State/province [44] 0 0
Belgrade
Country [45] 0 0
Serbia
State/province [45] 0 0
Kragujevac
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Badalona
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Bilbao
Country [50] 0 0
Spain
State/province [50] 0 0
Oviedo
Country [51] 0 0
Spain
State/province [51] 0 0
Pamplona
Country [52] 0 0
Spain
State/province [52] 0 0
San Sebastián
Country [53] 0 0
Sweden
State/province [53] 0 0
Göteborg
Country [54] 0 0
Sweden
State/province [54] 0 0
Huddinge
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Fulwood
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Glasgow
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Nottingham
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Oxford
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Taunton

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05988073
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05988073