Clinical trial NCT05988073: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multifocal Motor Neuropathy
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with MMN receiving standard of care at their treating physician.

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.


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

Primary outcomes:
measure: To characterize MMN patient profiles for participants
timeFrame: up to 24 months
measure: To assess the MMN disease management and disease course
timeFrame: up to 24 months
measure: To assess outcome measures specific to MMN disease and their evolution over time
timeFrame: up to 24 months
measure: To estimate the burden of MMN on participants' quality of life
timeFrame: up to 24 months
measure: To estimate the economic burden for participants with MMN
timeFrame: up to 24 months
measure: To collect data on relevant disease biomarkers
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Neuromuscular Clinical and Research Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Neurology - Bob Bove Neuroscience Institute
state: Arizona
city: Orange
country: United States
facility: UCI Health - ALS and Neuromuscular Center
state: California
city: Palo Alto
country: United States
facility: Stanford Medicine Health Care - Stanford Neuroscience Health Center
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Health - Rancho Mirage Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Health - Lawrence J. Ellison Ambulatory Care Center
state: California
city: San Francisco
country: United States
facility: UCSF Health - UCSF Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: YaleNewHavenHealth - Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Health - MedStar Georgetown University Hospital
state: District of Columbia
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center Inc
state: Florida
city: Tamarac
country: United States
facility: D&H National Research Centers - Tamarac Research Center
state: Florida
city: O'Fallon
country: United States
facility: Hospital Sisters Health System (HSHS) - St Elizabeth's Hospital
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Health System - Landon Center on Aging
state: Kansas
city: New Brunswick
country: United States
facility: Rutgers University - Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center - Neurological Institute of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center - Ohio State Martha Morehouse Outpatient Care
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University (OHSU) Hospital - Marquam Hill Campus
state: Oregon
city: Philadelphia
country: United States
facility: Penn Medicine - Penn Medicine University City
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine - Perelman Center for Advanced Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Cypress
country: United States
facility: Northwest Houston Neurology - Cypress
state: Texas
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liege
country: Belgium
facility: L'hopital de la Citadelle - Site Citadelle
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Pleven
country: Bulgaria
facility: Military Medical Academy - Military Hospital for Active Treatment Pleven
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
city: Montreal
country: Canada
facility: McGill University Health Centre - The Neuro (Montreal Neurological Institute-Hospital)
city: Quebec City
country: Canada
facility: CHU de Quebec - Hopital de L'enfant Jesus
city: Saskatoon
country: Canada
facility: University of Saskatchewan - University of Saskatchewan College of Medicine
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shangai
country: China
facility: Huashan Hospital of Fudan University
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno - Areal Bohunice
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Blegdamsvej
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Brest
country: France
facility: CHU Brest - Hopital La Cavale Blanche
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Pierre Wertheimer
city: Le Kremlin-Bicetre
country: France
facility: Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Bicetre
city: Lille
country: France
facility: CHU Lille - Hopital Salengro
city: Limoges
country: France
facility: CHU de Limoges - CHU Dupuytren 1
city: Marseille
country: France
facility: AP-HM - CHU Timone
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Nice
country: France
facility: CHU de Nice - Hopital Pasteur
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Pitie-Salpetriere
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Gießen
country: Germany
facility: Universitatsklinikum Giessen und Marburg - Campus Giessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Potsdam
country: Germany
facility: St. Josefs- Krankenhaus Potsdam- Sanssouci
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Gussago
country: Italy
facility: Fondazione Serena Onlus - NeMO Brescia
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino
city: Novara
country: Italy
facility: Universita degli Studi del Piemonte Orientale Amedeo Avogadro - Scuola di Medicina
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Pavia
country: Italy
facility: Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
city: Roma
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Andrea
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Bydgoszcz
country: Poland
facility: Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Bydgoszcz
city: Katowice
country: Poland
facility: Wielospecjalistyczna Poradnia Lekarska Synapsis
city: Kraków
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o.
city: Kraków
country: Poland
facility: Michalski i Partnerzy Lekarze Spolka Partnerska
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: CLINIREM Sp z o.o.
city: Lublin
country: Poland
facility: Rejdak Konrad Indywidualna Praktyka Lekarska
city: Lublin
country: Poland
facility: Centrum Medyczne Hope Clinic
city: Warsaw
country: Poland
facility: ETG Network - ETG Neuroscience
city: Constanţa
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
city: Belgrade
country: Serbia
facility: Univerzitetski klinicki centar Srbije
city: Kragujevac
country: Serbia
facility: Univerzitetski klinicki centar Kragujevac
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (HUGTP)
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: L&#39;Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset - MS - mottagning Sahlgrenska
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset - Huddinge
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust - Southmead Hospital Bristol
city: Fulwood
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
city: Glasgow
country: United Kingdom
facility: NHS Great Glasgow and Clyde - Queen Elizabeth University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Queen's Medical Centre
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
city: Salford
country: United Kingdom
facility: Northern Care Allicance NHS Foundation Trust - Salford Royal
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
city: Taunton
country: United Kingdom
facility: Somerset NHS Foundation Trust - Musgrove Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Study officials:
References: