Clinical Trials in Japan / NCT06706622
Active, not recruiting
Phase 3
A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
NCT06706622 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Multiple System Atrophy
Investigational drug(s) / intervention(s)
Amlenetug →Placebo
Amlenetug: Solution for infusion
Placebo: Commercially available saline solution
Study 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).
Eligibility
Key Inclusion 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.
Exclusion Criteria:
* 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.
Other protocol-defined inclusion and exclusion criteria apply.
Primary outcome measure(s)
- Rest of the World (RoW; All Countries Except European Union [EU] and Japan [JP]) Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression — Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint modified Unified Multiple System Atrophy Rating Scale (mUMSARS) score and time-to-death (any cause). - EU and JP Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression — Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (TS) and time-to-death (any cause).
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic - Vascular Center - Arizona | Phoenix | Arizona | |
| University of Arkansas for Medical Sciences (UAMS) - Medical Center | Little Rock | Arkansas | |
| University of California San Francisco - Sandler Neurosciences Center | San Francisco | California | |
| CenExel CBH - CenExel Rocky Mountain Clinical Research (CenExel RMCR) (Rocky Mountain Movement Di... | Englewood | Colorado | |
| Yale New Haven Health System | New Haven | Connecticut | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | |
| University of Florida-College of Medicine - Gainesville | Gainesville | Florida | |
| Indiana University (IU) Health-Senior Health Center | Indianapolis | Indiana | |
| Johns Hopkins University School of Medicine - The Johns Hopkins Multiple Sclerosis (MS) Center | Baltimore | Maryland | |
| Brigham and Women's Hospital (BWH) | Boston | Massachusetts | |
| Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - West Campus | Boston | Massachusetts | |
| QUEST Research Institute | Farmington | Michigan | |
| Mayo Clinic - Children's Center - Rochester | Rochester | Minnesota | |
| University of Nebraska Medical Center (UNMC) - The Lied Transplant Center | Omaha | Nebraska | |
| NYU Langone Health (NYU Langone Medical Center) | New York | New York | |
| Columbia University Irving Medical Center - The Neurological Institute of New York | New York | New York | |
| Cleveland Clinic - Neurological Institute - Cerebrovascular Center | Cleveland | Ohio | |
| University of Pennsylvania - Penn Comprehensive Neuroscience Center | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center-Magee-Womens Hospital (MWH) | Pittsburgh | Pennsylvania | |
| Vanderbilt University Medical Center (VUMC) - Vanderbilt Orthopaedic Institute-Nashville | Nashville | Tennessee | |
| University of Texas Southwestern Medical Center (UT Southwestern Medical Center) | Dallas | Texas | |
| Baylor College of Medicine (BCM) | Houston | Texas | |
| Inland Northwest Research (INWR) | Spokane | Washington | |
| University of New South Wales-Liverpool Hospital - Liverpool Cancer Therapy Centre | Liverpool | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Gold Coast University Hospital (GCUH) (Gold Coast Hospital) | Southport | Queensland | |
| The Alfred Hospital | Melbourne | Victoria | |
| The Ottawa Hospital - Centre for Rehabilitation Research and Development (CRRD) (The Institute fo... | Ottawa | Ontario | |
| University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC) | Toronto | Ontario | |
| Centre Hospitalier Universitaire de Rennes-Hopital Pontchaillou | Rennes | Brittany Region | |
| Centre Hospitalier Universitaire de Lille (CHU Lille) - Centre Regional de Pharmacovigilance (CRPV) | Lille | Hauts-de-France | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin - Tripode | Bordeaux | New Aquitaine | |
| Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) | Montpellier | Occitanie | |
| Centre Hospitalier Universitaire de Toulouse-Hopital Purpan | Toulouse | Occitanie | |
| 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 | |
| Universitaetsklinikum Erlangen - Psychiatrische und Psychotherapeutische Klinik | Erlangen | Bavaria | |
| Curiositas Ad Sanum - Haag In Oberbayern | Haag I.Ob | Bavaria | |
| Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Frauenheilkunde und G... | Munich | Bavaria |
+ 34 more sites — see the full list on the official registry below.
More H. Lundbeck A/S trials in Japan
A Study of Lu AF82422 in Participants With Multiple System Atrophy
Active, not recruiting
Other trials for the same condition
A Study of Lu AF82422 in Participants With Multiple System Atrophy
Active, not recruiting
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
Active, not recruiting
Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06706622 on ClinicalTrials.gov ↗ ← All trials in Japan