Clinical Trials in Spain / 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 Spain 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 | Scottsdale | Arizona | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| University of California, San Francisco Neurosciences Clinical Research Unit | San Francisco | California | |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | |
| Yale New Haven Health | North Haven | Connecticut | |
| Parkinson's Disease And Movement Disorder Center Of Boca Raton | Boca Raton | Florida | |
| University of Florida Norman Fixel Institute for Neurological Diseases | Gainesville | Florida | |
| Indiana Health University | Indianapolis | Indiana | |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| QUEST Research Institute | Farmington Hills | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| University Nebraska Medical Center | Omaha | Nebraska | |
| NYU Medical Center - Dysautonomia center | New York | New York | |
| Columbia University Medical Center - The Neurological Institute of New York | New York | New York | |
| Cleveland Clinic - Neurological Institute | Cleveland | Ohio | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | |
| Vanderbilt University Medical Center-Cognitive and Movement Disorders Group | Nashville | Tennessee | |
| University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic | Dallas | Texas | |
| Baylor College Of Medicine | Houston | Texas | |
| Inland Northwest Research | Spokane | Washington | |
| Liverpool Hospital - South Western Sydney Local Health District | Liverpool | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Gold Coast Hospital | Southport | Queensland | |
| The Alfred Hospital | Melbourne | Victoria | |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | |
| Toronto Western Hospital (TWH) | Toronto | Ontario | |
| 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 GmbH | Haag in Oberbayern | Germany | |
| Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern | München | Germany |
+ 34 more sites — see the full list on the official registry below.
More H. Lundbeck A/S trials in Spain
Other trials for the same condition
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 Spain