A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy

Multifocal Motor Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988073
• Other study ID #: ARGX-117-2202
• Status: Recruiting
• Start date: November 29, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: argenx
• Contact: Sabine Coppieters, MD
• Phone: 857-350-4834
• Email: ClinicalTrials[@]argenx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multifocal Motor Neuropathy
• Neuritis

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte
Bulgaria	Medical Center Medconsult Pleven OOD	Pleven
Bulgaria	University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov	Sofia
China	Huashan Hospital of Fudan University	Shangai
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Králové
France	CHU Angers	Angers
France	Hospices Civils de Lyon (HCL) - Hopital Pierre Wertheimer	Bron
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Fondazione Serena Onlus - NeMO Brescia	Gussago
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Istituto Neurologico Nazionale a Carattere Scientifico IRCCS	Pavia
Italy	Azienda Ospedaliero Universitaria Sant'Andrea	Roma
Japan	Dokkyo Medical University Hospital	Mibu
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital	Riga
Poland	Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Bydgoszcz	Bydgoszcz
Poland	Specjalistyczne Gabinety Sp. z o.o.	Kraków
Poland	Centrum Medyczne Hope Clinic	Lublin
Poland	CLINIREM Sp z o.o.	Lublin
Poland	Rejdak Konrad Indywidualna Praktyka Lekarska	Lublin
Poland	ETG Network - ETG Neuroscience	Warsaw
Romania	Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei	Constanta
Serbia	Univerzitetski klinicki centar Srbije	Belgrade
Serbia	Univerzitetski klinicki centar Kragujevac	Kragujevac
Sweden	Sahlgrenska Universitetssjukhuset - MS - mottagning Sahlgrenska	Göteborg
Sweden	Karolinska Universitetssjukhuset - Huddinge	Huddinge
United States	Northwest Houston Neurology - Cypress	Cypress	Texas
United States	Hospital Sisters Health System (HSHS) - St Elizabeth's Hospital	O'Fallon	Illinois
United States	The Neurology Group	Pomona	California
United States	HonorHealth Neurology - Bob Bove Neuroscience Institute	Scottsdale	Arizona
United States	D&H National Research Centers - Tamarac Research Center	Tamarac	Florida
United States	MedStar Health - MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
argenx

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Czechia,  France,  Italy,  Japan,  Latvia,  Poland,  Romania,  Serbia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize MMN patient profiles for participants		up to 24 months
Primary	To assess the MMN disease management and disease course		up to 24 months
Primary	To assess outcome measures specific to MMN disease and their evolution over time		up to 24 months
Primary	To estimate the burden of MMN on participants' quality of life		up to 24 months
Primary	To estimate the economic burden for participants with MMN		up to 24 months
Primary	To collect data on relevant disease biomarkers		up to 24 months