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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

357

Start Date

2024-12-03

Completion Date

2029-10-25

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Amlenetug

Solution for infusion

DRUG

Placebo

Commercially available saline solution

Locations (74)

Mayo Clinic

Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California, San Francisco Neurosciences Clinical Research Unit

San Francisco, California, United States

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Yale New Haven Health

North Haven, Connecticut, United States

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, United States

University of Florida Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Indiana Health University

Indianapolis, Indiana, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

University Nebraska Medical Center

Omaha, Nebraska, United States

NYU Medical Center - Dysautonomia center

New York, New York, United States

Columbia University Medical Center - The Neurological Institute of New York

New York, New York, United States

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic

Dallas, Texas, United States

Baylor College Of Medicine

Houston, Texas, United States

Inland Northwest Research

Spokane, Washington, United States

Liverpool Hospital - South Western Sydney Local Health District

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Gold Coast Hospital

Southport, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Toronto Western Hospital (TWH)

Toronto, Ontario, Canada

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

Bordeaux, France

Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

Lille, France

CHU - Hospital de la Timone

Marseille, France

Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac

Montpellier, France

Chu De La Pitie-Salpetriere

Paris, France

Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou

Rennes, France

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, France

Movement Disorders Clinic

Beelitz-Heilstätten, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Curiositas-ad-sanum Beratungs-und Studien GmbH

Haag in Oberbayern, Germany

Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

University Hospital Tuebingen

Tübingen, Germany

IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna

Bologna, Italy

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

AOU Universita della Campania Luigi Vanvitelli

Naples, Italy

A.O.U. Pisana-Ospedale S. Chiara

Pisa, Italy

Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

Salerno, Italy

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Miyagi, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

National Center Hospital, National Center of Neurology and Psychiatry

Kodaira-shi, Tokyo, Japan

Tottori University Hospital

Yonago-shi, Tottori, Japan

Saitama Medical University Hospital

Iruma-gun, Japan

Niigata University Medical And Dental Hospital

Niigata, Japan

Keio University Hospital

Tokyo, 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 Vall d'Hebron

Barcelona, Spain

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

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona (Spain), Spain

Hospital Universitario de La Princesa

Madrid, Spain

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

Seville, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...

Valencia, Spain

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, United Kingdom

Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...

Oxford, Oxfordshire, United Kingdom

Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde

Glasgow, Scotland, United Kingdom

Clinical Ageing Reseach Unit

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust

Exeter, United Kingdom

The National Hospital for Neurology and Neurosurgery

London, United Kingdom