ACTIVE_NOT_RECRUITING

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

Conditions

Multiple System Atrophy Lu AF82422 MSA Neurodegenerative Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12-03

Study Completion:2029-10-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06706622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 (that is, 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.	* The participant has previously been dosed with amlenetug. * The participant has taken any active IMP within 3 months or 5 half lives of that product, whichever is longer, prior to the first dose of IMP. * The participant has 2 or more first degree relatives with a history of MSA. * The participant, if of MSA-P subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the Screening Visit. * The participant has evidence (clinically or on magnetic resonance imaging (MRI)) and/or history of any clinically significant disease or condition other than MSA, that is, in the investigator's opinion, likely to affect CNS functioning, e.g., serious neurological disorder, other intracranial or systemic disease. * The participant has a current diagnosis of movement disorders that could mimic MSA, e.g., Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. Participants who have previously been incorrectly diagnosed with Parkinson's disease will not be excluded.

Inclusion Criteria

Exclusion Criteria

* 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 (that is, 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.

* The participant has previously been dosed with amlenetug.
* The participant has taken any active IMP within 3 months or 5 half lives of that product, whichever is longer, prior to the first dose of IMP.
* The participant has 2 or more first degree relatives with a history of MSA.
* The participant, if of MSA-P subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the Screening Visit.
* The participant has evidence (clinically or on magnetic resonance imaging (MRI)) and/or history of any clinically significant disease or condition other than MSA, that is, in the investigator's opinion, likely to affect CNS functioning, e.g., serious neurological disorder, other intracranial or systemic disease.
* The participant has a current diagnosis of movement disorders that could mimic MSA, e.g., Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. Participants who have previously been incorrectly diagnosed with Parkinson's disease will not be excluded.

Contacts and Locations

Principal Investigator

Email contact via H. Lundbeck A/S

STUDY_DIRECTOR

H. Lundbeck A/S

Study Locations (Sites)

Mayo Clinic

Scottsdale, Arizona, 85259

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

University of California, San Francisco Neurosciences Clinical Research Unit

San Francisco, California, 94158

United States

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, 80113

United States

Yale New Haven Health

North Haven, Connecticut, 06473

United States

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, 33486

United States

University of Florida Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608

United States

Indiana Health University

Indianapolis, Indiana, 46202

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

QUEST Research Institute

Farmington Hills, Michigan, 48334

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

University Nebraska Medical Center

Omaha, Nebraska, 68198-8440

United States

NYU Medical Center - Dysautonomia center

New York, New York, 10016

United States

Columbia University Medical Center - The Neurological Institute of New York

New York, New York, 10032-3726

United States

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, 44195

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19107

United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

Nashville, Tennessee, 37232

United States

University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic

Dallas, Texas, 75390-8565

United States

Baylor College Of Medicine

Houston, Texas, 77030

United States

Inland Northwest Research

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: H. Lundbeck A/S

Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, H. Lundbeck A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03

Study Completion Date2029-10-25

Study Record Updates

Study Start Date2024-12-03

Study Completion Date2029-10-25

Terms related to this study

Keywords Provided by Researchers

Lu AF82422
MSA
Neurodegenerative Disorder

Additional Relevant MeSH Terms

Multiple System Atrophy