Multifocal Motor Neuropathy Clinical Trials

Find Multifocal Motor Neuropathy Clinical Trials Near You

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy

Status: Recruiting
Location: See all (106) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months. More information can be found here: https://clinicaltrials.argenx.com/empassion

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Is at least 18 years of age and the local legal age of consent for clinical studies

• Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines

• Has responded to IVIg in the past 5 years.

• Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle

• Is receiving a maintenance regimen (no change in frequency, and no change in dose \>10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)

• Minimum converted weekly IVIg dose of ≥0.125 g/kg

• Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration

Locations
United States
Arizona
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
ACTIVE_NOT_RECRUITING
Scottsdale
California
The Neurology Group
ACTIVE_NOT_RECRUITING
Pomona
Samir Macwan, M.D., Inc.
ACTIVE_NOT_RECRUITING
Rancho Mirage
University of California San Francisco
ACTIVE_NOT_RECRUITING
San Francisco
Colorado
University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)
ACTIVE_NOT_RECRUITING
Aurora
Connecticut
Yale University School of Medicine
ACTIVE_NOT_RECRUITING
New Haven
Washington, D.c.
Medstar Health Research Institute
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
EZR Research LLC
ACTIVE_NOT_RECRUITING
Boca Raton
Healthcare Innovations Institute, LLC
ACTIVE_NOT_RECRUITING
Coral Springs
University of Miami Miller School of Medicine
ACTIVE_NOT_RECRUITING
Miami
University of South Florida
ACTIVE_NOT_RECRUITING
Tampa
Illinois
Northwestern University
ACTIVE_NOT_RECRUITING
Chicago
Indiana
Indiana University Health Neuroscience Center
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
ACTIVE_NOT_RECRUITING
Fairway
Maryland
Perelman Center for Advanced Medicine
ACTIVE_NOT_RECRUITING
Columbia
UC Irvine - MDA ALS and Neuromuscular Center
ACTIVE_NOT_RECRUITING
Columbia
Minnesota
University of Minnesota
ACTIVE_NOT_RECRUITING
Minneapolis
North Carolina
University of North Carolina at Chapel Hill
ACTIVE_NOT_RECRUITING
Morrisville
New York
Dent Neurologic Institute Amherst
ACTIVE_NOT_RECRUITING
Amherst
Columbia University Medical Center
ACTIVE_NOT_RECRUITING
New York
Ohio
The Cleveland Clinic Foundation
ACTIVE_NOT_RECRUITING
Cleveland
Oregon
Oregon Health and Science University
ACTIVE_NOT_RECRUITING
Portland
Texas
National Neuromuscular Research Institute
ACTIVE_NOT_RECRUITING
Austin
NeuroCarePlus
ACTIVE_NOT_RECRUITING
Houston
Other Locations
Australia
Royal Melbourne Hospital
ACTIVE_NOT_RECRUITING
Parkville
Gold Coast University Hospital
ACTIVE_NOT_RECRUITING
Southport
Brain and Mind Center
ACTIVE_NOT_RECRUITING
Sydney
Princess Alexandra Hospital
ACTIVE_NOT_RECRUITING
Woolloongabba
Austria
Universitätsklinikum AKH Wien
ACTIVE_NOT_RECRUITING
Vienna
Belgium
UZ Antwerpen
ACTIVE_NOT_RECRUITING
Edegem
UZ Leuven
ACTIVE_NOT_RECRUITING
Leuven
Hôpital de la Citadelle
ACTIVE_NOT_RECRUITING
Liège
Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto
ACTIVE_NOT_RECRUITING
Ribeirão Preto
Sociedade de Ensino Superior Estacio de Sa Ltda
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Escola Bahiana de Medicina e Saude Publica
ACTIVE_NOT_RECRUITING
Salvador
PSEG Centro de Pesquisa Clínica
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Neuro-Outaouais Clinic
ACTIVE_NOT_RECRUITING
Gatineau
London Health Sciences Centre
ACTIVE_NOT_RECRUITING
London
St. Paul's Neurology Associates
ACTIVE_NOT_RECRUITING
Vancouver
China
Huashan Hospital Fudan University
ACTIVE_NOT_RECRUITING
Shanghai
Denmark
Aarhus Universitetshospital
ACTIVE_NOT_RECRUITING
Aarhus
Rigshospitalet-Inge Lehmanns Vej 8
ACTIVE_NOT_RECRUITING
Copenhagen
France
CHU de Bordeaux - Hôpital Pellegrin
ACTIVE_NOT_RECRUITING
Bordeaux
CHU de Brest - Hôpital La Cavale Blanche
ACTIVE_NOT_RECRUITING
Brest
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
ACTIVE_NOT_RECRUITING
Bron
AP-HP - Hôpital Bicêtre
ACTIVE_NOT_RECRUITING
Le Kremlin-bicêtre
Hôpital Roger Salengro
ACTIVE_NOT_RECRUITING
Lille
CHU Limoges - Dupuytren 1
ACTIVE_NOT_RECRUITING
Limoges
AP-HM- Hôpital de La Timone
ACTIVE_NOT_RECRUITING
Marseille
AP-HM- Hôpital de La Timone
ACTIVE_NOT_RECRUITING
Marseille
CHU de Nice-Hôpital Pasteur
ACTIVE_NOT_RECRUITING
Nice
AP-HP - Hôpital de la Pitié Salpétrière
ACTIVE_NOT_RECRUITING
Paris
CHU de Strasbourg - Hôpital de Hautepierre
ACTIVE_NOT_RECRUITING
Strasbourg
Germany
Universitätsklinikum Essen
ACTIVE_NOT_RECRUITING
Essen
Universität Georg August
ACTIVE_NOT_RECRUITING
Göttingen
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
ACTIVE_NOT_RECRUITING
Lübeck
Universitätsklinikum Münster
ACTIVE_NOT_RECRUITING
Münster
Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH
ACTIVE_NOT_RECRUITING
Potsdam
Universitätsklinikum Würzburg
ACTIVE_NOT_RECRUITING
Würzburg
Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
ACTIVE_NOT_RECRUITING
Chaïdári
AHEPA University General Hospital of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
Italy
Azienda Ospedaliera Universitaria Careggi
ACTIVE_NOT_RECRUITING
Florence
Ospedale Policlinico San Martino IRCCS
ACTIVE_NOT_RECRUITING
Genova
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
ACTIVE_NOT_RECRUITING
Gussago
Az. Ospedaliera Universitaria Policlinico G. Martino
ACTIVE_NOT_RECRUITING
Messina
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
ACTIVE_NOT_RECRUITING
Milan
Ospedale San Raffaele S.r.l.
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliero-Universitaria Sant'Andrea
ACTIVE_NOT_RECRUITING
Roma
Fondazione PTV Policlinico Tor Vergata
ACTIVE_NOT_RECRUITING
Roma
IRCCS Istituto Clinico Humanitas
ACTIVE_NOT_RECRUITING
Rozzano
Japan
Institute of Science Tokyo Hospital
ACTIVE_NOT_RECRUITING
Bunkyō City
Juntendo University Hospital
ACTIVE_NOT_RECRUITING
Bunkyō City
Chiba University Hospital
ACTIVE_NOT_RECRUITING
Chūōku
National Center of Neurology and Psychiatry
ACTIVE_NOT_RECRUITING
Kodaira
Nagoya University Hospital
ACTIVE_NOT_RECRUITING
Nagoya
Teikyo University Hospital
RECRUITING
Tabashi City
Yamaguchi University Hospital
ACTIVE_NOT_RECRUITING
Ube
Latvia
Pauls Stradins Clinical University Hospital
ACTIVE_NOT_RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
ACTIVE_NOT_RECRUITING
Kaunas
Netherlands
Amsterdam UMC
ACTIVE_NOT_RECRUITING
Amsterdam
Norway
Oslo Universitetssykehus HF, Ullevål
ACTIVE_NOT_RECRUITING
Oslo
Poland
MICS Centrum Medyczne Bydgoszcz
ACTIVE_NOT_RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
ACTIVE_NOT_RECRUITING
Katowice
SP ZOZ Szpital Uniwersytecki w Krakowie
ACTIVE_NOT_RECRUITING
Krakow
Galen Clinic -- Lublin
ACTIVE_NOT_RECRUITING
Lublin
UCK WUM, Centralny Szpital Kliniczny
ACTIVE_NOT_RECRUITING
Warsaw
Portugal
ULS de Santo António, EPE - Hospital de Santo António
ACTIVE_NOT_RECRUITING
Porto
Serbia
University Clinical Center of Serbia
ACTIVE_NOT_RECRUITING
Belgrade
Slovakia
Univerzitna nemocnica Bratislava
ACTIVE_NOT_RECRUITING
Bratislava
Univerzitna nemocnica MARTIN
ACTIVE_NOT_RECRUITING
Martin
Slovenia
University Medical Centre Ljubljana
ACTIVE_NOT_RECRUITING
Ljubljana
Spain
Hospital General Universitario Dr. Balmis
ACTIVE_NOT_RECRUITING
Alicante
Hospital Universitario Germans Trias i Pujol
ACTIVE_NOT_RECRUITING
Badalona
Hospital de La Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario de Bellvitge
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Clinico San Carlos
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario de Basurto
ACTIVE_NOT_RECRUITING
Madrid
Hospital Quironsalud Malaga
ACTIVE_NOT_RECRUITING
Málaga
Hospital Universitario de Donostia
ACTIVE_NOT_RECRUITING
San Sebastián
Switzerland
Inselspital - Universitätsspital Bern
ACTIVE_NOT_RECRUITING
Bern
United Kingdom
Queen Elizabeth University Hospital
ACTIVE_NOT_RECRUITING
Glasgow
John Radcliffe Hospital
ACTIVE_NOT_RECRUITING
Oxford
Salford Royal Hospital
ACTIVE_NOT_RECRUITING
Salford
Royal Hallamshire Hospital
ACTIVE_NOT_RECRUITING
Sheffield
Musgrove Park Hospital
ACTIVE_NOT_RECRUITING
Taunton
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2029-12
Participants
Target number of participants: 115
Treatments
Experimental: Part A - empasiprubart + IVIg-placebo
During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
Active_comparator: Part A - IVIg + empasiprubart-placebo
During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
Experimental: Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov