Active, not recruitingPhase 2
A Study of Lu AF82422 in Participants With Multiple System Atrophy
Key facts
- Who runs it
- H. Lundbeck A/S
- Where
- Boca Raton, Boston, Chicago, Englewood, Fountain Valley, Gainesville, Glenview, Hershey, La Jolla, New York, Omaha, Philadelphia, Pittsburgh, Rochester, and San Francisco, United StatesSee the 16 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 64 people enrolled
- Started
- 16 Nov 2021
- Expected to end
- 7 Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Lu AF82422
- Placebo
- Record updated
- 13 April 2026
Who can take part
- Age
- 40 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit
- The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator
- The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit
- The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥22 at the Screening Visit; Open-label Extension Entry Criteria
- The participant has completed the EoT Visit and did not withdraw in the DBP
- The participant has consented to participate in the OLE
- The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024
- The participant is, in the Investigator's opinion, likely to comply with the protocol
- The participant has not received any other Investigational product since the EOoTDBP Visit
Who cannot take part
- The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months
- The participant has any past or current treatment with an active vaccine targeting α-synuclein
- The participant has 2 or more blood relatives with a history of MSA
- The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease)
- The participant has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' 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; Other inclusion and exclusion criteria may apply
Where in United States
Also in 1 other country, 3 sites
- Parkinson's Disease and Movement Disorder Center of Boca RatonBoca Raton, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Rush University Medical Center, Rush University Cancer CenterChicago, United StatesNo longer taking part
- CenExel Rocky Mountain Clinical Research, LLCEnglewood, United StatesNo longer taking part
- The Parkinsons and Movement Disorder InstituteFountain Valley, United StatesNo longer taking part
- University of Florida, Norman Fixel Institute for Neurological DiseasesGainesville, United StatesNo longer taking part
- Endeavor Health- Glenbrook HospitalGlenview, United StatesNo longer taking part
- Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)Hershey, United StatesNo longer taking part
- University of California San DiegoLa Jolla, United StatesNo longer taking part
- Columbia University Medical Center The Neurological Institute of New YorkNew York, United StatesNo longer taking part
- NYU Langone Health Medical CenterNew York, United StatesNo longer taking part
- University Nebraska Medical CenterOmaha, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- University of PittsburghPittsburgh, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- University of California, San Francisco Neurosciences Clinical Research UnitSan Francisco, United StatesNo longer taking part
About the trial
What the trial wants to find out
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
The 2 groups in the trial
- Lu AF82422Treatment being tested
Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks. In the optional OLE, all participants will receive Lu AF82422 IV infusion starting on Day 1 of the OLE up to week 188.
- PlaceboTreatment being tested
Participants in the DBP will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of Lu AF82422 in Patients With Multiple System Atrophy
- Publications
- Record updated
- 13 April 2026