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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
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
Germany
State/province [27] 0 0
Gießen
Country [28] 0 0
Germany
State/province [28] 0 0
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
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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