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ACTIVE NOT RECRUITING
NCT06706622
PHASE3

A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

The main goal of this trial is to evaluate the efficacy and safety of amlenetug for the treatment of participants with Multiple System Atrophy (MSA).

Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

401

Start Date

2024-12-03

Completion Date

2029-10-25

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

Amlenetug

Solution for infusion

DRUG

Placebo

Commercially available saline solution

Locations (74)

Mayo Clinic - Vascular Center - Arizona

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences (UAMS) - Medical Center

Little Rock, Arkansas, United States

University of California San Francisco - Sandler Neurosciences Center

San Francisco, California, United States

CenExel CBH - CenExel Rocky Mountain Clinical Research (CenExel RMCR) (Rocky Mountain Movement Di...

Englewood, Colorado, United States

Yale New Haven Health System

New Haven, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

University of Florida-College of Medicine - Gainesville

Gainesville, Florida, United States

Indiana University (IU) Health-Senior Health Center

Indianapolis, Indiana, United States

Johns Hopkins University School of Medicine - The Johns Hopkins Multiple Sclerosis (MS) Center

Baltimore, Maryland, United States

Brigham and Women's Hospital (BWH)

Boston, Massachusetts, United States

Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - West Campus

Boston, Massachusetts, United States

QUEST Research Institute

Farmington, Michigan, United States

Mayo Clinic - Children's Center - Rochester

Rochester, Minnesota, United States

University of Nebraska Medical Center (UNMC) - The Lied Transplant Center

Omaha, Nebraska, United States

NYU Langone Health (NYU Langone Medical Center)

New York, New York, United States

Columbia University Irving Medical Center - The Neurological Institute of New York

New York, New York, United States

Cleveland Clinic - Neurological Institute - Cerebrovascular Center

Cleveland, Ohio, United States

University of Pennsylvania - Penn Comprehensive Neuroscience Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center-Magee-Womens Hospital (MWH)

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center (VUMC) - Vanderbilt Orthopaedic Institute-Nashville

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center (UT Southwestern Medical Center)

Dallas, Texas, United States

Baylor College of Medicine (BCM)

Houston, Texas, United States

Inland Northwest Research (INWR)

Spokane, Washington, United States

University of New South Wales-Liverpool Hospital - Liverpool Cancer Therapy Centre

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Gold Coast University Hospital (GCUH) (Gold Coast Hospital)

Southport, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Ottawa Hospital - Centre for Rehabilitation Research and Development (CRRD) (The Institute fo...

Ottawa, Ontario, Canada

University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC)

Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Rennes-Hopital Pontchaillou

Rennes, Brittany Region, France

Centre Hospitalier Universitaire de Lille (CHU Lille) - Centre Regional de Pharmacovigilance (CRPV)

Lille, Hauts-de-France, France

Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin - Tripode

Bordeaux, New Aquitaine, France

Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)

Montpellier, Occitanie, France

Centre Hospitalier Universitaire de Toulouse-Hopital Purpan

Toulouse, Occitanie, France

AP-HM- Hôpital de La Timone

Marseille, France

CHU de la Pitié-Salpêtrière

Paris, France

Universitaetsklinikum Tuebingen - Universitaetsklinik fuer Psychiatrie und Psychotherapie

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen - Psychiatrische und Psychotherapeutische Klinik

Erlangen, Bavaria, Germany

Curiositas Ad Sanum - Haag In Oberbayern

Haag I.Ob, Bavaria, Germany

Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Frauenheilkunde und G...

Munich, Bavaria, Germany

Universitaetsklinikum Muenster (UKM) - Medizinische Klinik A

Münster, North Rhine-Westphalia, Germany

Movement Disorders Clinic Beelitz-Heilstätten

Beelitz-Heilstätten, Germany

Universita di Bologna - IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Centro Dino Ferrari

Milan, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, Italy

Universita degli Studi della Campania "Luigi Vanvitelli" - Centro Cefalee

Naples, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...

Pisa, Italy

Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio e Ruggi d'Aragona - Scuola Medica Sa...

Salerno, Italy

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake-Shi, Aichi-ken, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

National Hospital Organization Sendai Nishitaga National Hospital

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Saitama Medical University (SMU) - Moro Hospital

Iruma-shi, Saitama, Japan

Juntendo University-Juntendo University Hospital

Bunkyō City, Tokyo-To, Japan

National Center of Neurology and Psychiatry-National Center Hospital

Kodaira-shi, Tokyo-To, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo-To, Japan

Tottori University Hospital

Yonago-shi, Tottori, Japan

Kyung Hee University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

Seville, Seville, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Institut Clinic de Neurociencies (ICN)

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau - Institut de Recerca de l'Hospital de la Santa Creu i Sant ...

Barcelona, Spain

Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa - Instituto de Inves...

Madrid, Spain

Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Newcastle University - Clinical Ageing Research Unit (CARU)

Newcastle upon Tyne, North East, United Kingdom

Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital (Hope Hospital)

Salford, North West, United Kingdom, United Kingdom

Oxford University Hospitals NHS Foundation Trust-Oxford Centre for Functional MRI of the Brain (F...

Oxford, South East, United Kingdom

NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...

Glasgow, South Western Scotland, United Kingdom

Royal Devon University Healthcare NHS Foundation Trust - Royal Devon and Exeter Hospital (RD&E) -...

Exeter, South West, United Kingdom

University College London Hospitals NHS Foundation Trust-National Hospital for Neurology & Neuros...

London, United Kingdom