Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy
Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• The participant has a diagnosis of clinically established multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), or clinically probable MSA-P or MSA-C, according to the 2022 Movement Disorders Society (MDS) criteria for the diagnosis of MSA at the Screening Visit.
• The participant had onset of motor MSA symptoms (i.e., parkinsonian and/or cerebellar) within 5 years prior to the Screening Visit in the judgement of the investigator.
• The participant has an anticipated survival of \>3 years, in the opinion of the investigator, at the Screening Visit.
• The participant has suitable peripheral venous access for investigational medicinal product (IMP) administration and blood sampling.
• The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Mayo Clinic
RECRUITING
Scottsdale
California
University of California, San Francisco Neurosciences Clinical Research Unit
RECRUITING
San Francisco
Colorado
CenExel Rocky Mountain Clinical Research, LLC
RECRUITING
Englewood
Connecticut
Yale New Haven Health
RECRUITING
North Haven
Florida
Parkinson's Disease And Movement Disorder Center Of Boca Raton
RECRUITING
Boca Raton
University of Florida Norman Fixel Institute for Neurological Diseases
RECRUITING
Gainesville
Indiana
Indiana Health University
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Michigan
QUEST Research Institute
RECRUITING
Farmington Hills
Minnesota
Mayo Clinic
RECRUITING
Rochester
Nebraska
University Nebraska Medical Center
RECRUITING
Omaha
New York
Columbia University Medical Center - The Neurological Institute of New York
RECRUITING
New York
Ohio
Cleveland Clinic - Neurological Institute
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
University Of Pittsburgh
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic
RECRUITING
Dallas
Baylor College Of Medicine
RECRUITING
Houston
Washington
Inland Northwest Research
RECRUITING
Spokane
Other Locations
Australia
Liverpool Hospital - South Western Sydney Local Health District
RECRUITING
Liverpool
The Alfred Hospital
RECRUITING
Melbourne
Gold Coast Hospital
RECRUITING
Southport
Westmead Hospital
RECRUITING
Westmead
France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
RECRUITING
Bordeaux
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
RECRUITING
Lille
CHU - Hospital de la Timone
RECRUITING
Marseille
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac
RECRUITING
Montpellier
Chu De La Pitie-Salpetriere
RECRUITING
Paris
Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou
RECRUITING
Rennes
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
RECRUITING
Toulouse
Germany
Movement Disorders Clinic
RECRUITING
Beelitz-heilstätten
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Curiositas-ad-sanum Beratungs-und Studien GmbH
RECRUITING
Haag In Oberbayern
University Hospital Tuebingen
RECRUITING
Tübingen
Italy
IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
RECRUITING
Bologna
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
RECRUITING
Milan
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
AOU Universita della Campania Luigi Vanvitelli
RECRUITING
Napoli
A.O.U. Pisana-Ospedale S. Chiara
RECRUITING
Pisa
Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
RECRUITING
Salerno
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Gifu University Hospital
RECRUITING
Gifu
Saitama Medical University Hospital
RECRUITING
Iruma-gun
National Center Hospital, National Center of Neurology and Psychiatry
RECRUITING
Kodaira-shi
Niigata University Medical And Dental Hospital
RECRUITING
Niigata
Hokkaido University Hospital
RECRUITING
Sapporo
National Hospital Organization Sendai Nishitaga Hospital
RECRUITING
Sendai
Keio University Hospital
RECRUITING
Tokyo
Fujita Health University Hospital
RECRUITING
Toyoake
Tottori University Hospital
RECRUITING
Yonago-shi
Republic of Korea
Kyung Hee University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona (spain)
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
RECRUITING
Seville
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...
RECRUITING
Valencia
United Kingdom
Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust
RECRUITING
Exeter
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde
RECRUITING
Glasgow
The National Hospital for Neurology and Neurosurgery
RECRUITING
London
Clinical Ageing Reseach Unit
RECRUITING
Newcastle Upon Tyne
Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...
RECRUITING
Oxford
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
RECRUITING
Salford
Contact Information
Primary
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
+45 36301311
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2029-10-25
Participants
Target number of participants: 360
Treatments
Experimental: Lu AF82422 Low Dose
Participants will receive Lu AF82422 by intravenous infusion
Experimental: Lu AF82422 High Dose
Participants will receive Lu AF82422 by intravenous infusion
Placebo_comparator: Placebo
Participants will receive commercially available saline solution for infusion
Related Therapeutic Areas
Sponsors
Leads: H. Lundbeck A/S