Multiple System AtrophyPhase 2AMULETNCT05104476
A Study of Lu AF82422 in Participants With Multiple System Atrophy
A Phase 2 study testing Lu AF82422 in people with Multiple System Atrophy, run by H. Lundbeck A/S at 19 sites in 2 countries.
Trial summary
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Lu AF82422
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 16 Nov 2021to 7 Mar 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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 join
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States16 sites
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton, Florida, 33486
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center, Rush University Cancer Center
Chicago, Illinois, 60612
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, 80113
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, 92708
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Endeavor Health - Glenbrook Hospital
Glenview, Illinois, 60026
Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)
Hershey, Pennsylvania, 17033
University of California - San Diego
La Jolla, California, 92037
NYU Langone Health Medical Center
New York, New York, 10016
Columbia University Medical Center - The Neurological Institute of New York
New York, New York, 10032
University Nebraska Medical Center
Omaha, Nebraska, 68198-8440
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco, California, 94158
Japan3 sites
Gifu University Hospital
Gifu, Gifu, 501-1194
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Miyagi, 982-8555
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
About this study
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
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
Read the detailed description
This study will consist of a double-blind period (DBP) and will include an optional open-label treatment extension (OLE) period. Participants in the DBP will be randomized to Lu AF82422 or placebo (2:1). All participants entering the OLE will receive Lu AF82422 during the OLE.
- Conditions
- Multiple System Atrophy
- Being tested
- Lu AF82422, Placebo
- Keywords
- Multiple System Atrophy, Neurodegenerative Disorder, Autonomic Failure
- Medical subject headings
- Multiple System Atrophy, Neurodegenerative Diseases, Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF82422Drug
Solution for infusion
PlaceboDrug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Lu AF82422 | Experimental | 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. Receives: Drug: Lu AF82422 |
| Placebo | Experimental | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)
The primary endpoint assessed disease progression by a Bayesian repeated measures model on UMSARS TS. Reported here is the estimated slowing (%) of clinical progression in participants receiving Lu AF82422 relative to those receiving placebo. UMSARS is a combined clinician and patient-reported outcome assessment developed to provide a surrogate measure of disease progression in multiple system atrophy (MSA). UMSARS TS was obtained by the sum of the items from Part I and Part II. Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks and Part II consists of a clinical examination of key MSA motor signs and symptoms. UMSARS TS score was the sum of all items and ranged from 0 (no impairment) to 104 (severe impairment). A higher score indicated greater impairment.
Measured: Baseline up to Week 72
Secondary outcomes (18)
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP
UMSARS is a combined clinician and patient-reported scale to assess motor impairment in MSA participants. UMSARS TS was obtained by the sum of the items from Part I and Part II. Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks (12 items) rated on a scale ranging from 0 = not affected to 4 = unable to do the activity. Part I total score ranged between 0 to 48 (higher score indicated greater impairment). Part II consists of a clinical examination of key MSA motor signs and symptoms (14 items) rated on a scale ranging from 0 = normal to 4 = marked/severe impairment. Part II total score ranged between 0 and 56 (higher score indicated greater impairment). UMSARS TS score was the sum of all 26 items and ranged from 0 (no impairment) to 104 (severe impairment). A higher score indicated greater impairment. LS mean and SE were calculated using MMRM.
Measured: Baseline, Weeks 48 and 72
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP
UMSARS Part 1 assesses historical information on symptoms and activities of daily living over the past 2 weeks as reported by participants and caregivers (12 items) rated on a scale ranging from 0 to 4; with 0 = not affected/normal 1= mildly affected/impaired, 2= moderately affected/impaired, 3= severely affected/impaired, and 4 = helpless or entirely affected/impaired. The modified UMSARS part I (mUMSARS) score was derived by collapsing the response option 0 and 1 within each item (0 \& 1 =1). Hence, the mUMSARS score ranged from 12 to 48 (higher score indicated greater impairment). LS mean and SE were calculated using MMRM.
Measured: Baseline, Weeks 48 and 72
Change From Baseline in the UMSARS Part I Scores at the EOT DBP
UMSARS Part 1 assesses historical information on symptoms and activities of daily living over the past 2 weeks as reported by participants and caregivers (12 items: speech, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function, and bowel function) each rated on a scale ranging from 0 to 4; with 0 = not affected/normal 1= mildly affected/impaired, 2= moderately affected/impaired, 3= severely affected/impaired, and 4 = helpless or entirely affected/impaired. Part I total score ranged between 0 to 48 (higher score indicated greater impairment). LS mean and SE were calculated using MMRM.
Measured: Baseline, Weeks 48 and 72
Change From Baseline in the UMSARS Part II Scores at the EOT DBP
UMSARS Part II consists of a clinical examination of key MSA motor signs and symptoms (14 items: facial expression, speech, ocular motor dysfunction, tremor at rest, action tremor, increased tone, rapid alternating movements of hands, finger taps, leg agility, heel-knee-shin test, arising from chair, posture, body sway, gait) each rated on a scale ranging from 0 to 4; with 0 = not affected/normal 1= mildly affected/impaired, 2= moderately affected/impaired, 3= severely affected/impaired, and 4 = helpless or entirely affected/impaired. Part II total score ranged between 0 and 56 (higher score indicated greater impairment). LS mean and SE were calculated using MMRM.
Measured: Baseline, Weeks 48 and 72
Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP
The SE-ADL is a combined participant- and clinician-reported scale to assess participants physical functioning in activities in daily living to grade functional status. For this study, only the clinician-rated part was administered. The SE-ADL scale uses percentages to represent how much effort and dependence on others, participants need to complete daily chores. The SE-ADL scale ranged from 0% indicating worst possible function (fully dependent) to 100% indicating no impairment (completely independent). LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP
The CGI-S was administered by an experienced neurologist familiar with MSA participants to make an expert clinical global judgement about the severity of the disease across various time points. The rating was based upon observed and reported symptoms, behaviour, and function in the past seven days. The CGI-S was rated on a scale ranging from 0 to 4 (whereas the 0 = normal, not impaired; 1 = mildly impaired; 2 = moderately impaired; 3 = severely impaired; 4 = extremely impaired). LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 in the DBP
The PGI-S is a self-reported single item to evaluate all aspects of participants' MSA symptoms. Participants were asked to choose the response that best described the severity of their MSA symptoms over the past week. The question was rated on a 5-point scale ranging from 0 to 4 (0 = none; 1 = minor; 2 = moderate; 3 = severe; 4 = very severe). LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 in the DBP
The OGI-S is a single-question carer/observer-reported outcome to evaluate all aspects of participants' MSA symptoms. Carer/observers were asked to choose the response that best described the observed severity of MSA symptoms in the person they care for over the past week. The question was rated on a 5-point scale ranging from 0 to 4 (0 = none; 1 = minor; 2 = moderate; 3 = severe; 4 = very severe). LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Total Score at Week 48 in the DBP
The COMPASS Select, a participant-reported scale, consists of a subset of 36 items derived from the original COMPASS, to assess severity of autonomic symptoms in MSA during the last year. The COMPASS Select includes 3 domains related to blood pressure control: syncope, orthostatic intolerance, and vasomotor symptoms; and 3 domains focused on symptoms of disturbed secretomotor, bladder, and sleep function. The COMPASS Select Change is a derivate of COMPASS Select, consisting of 16 items in which participants were asked to score their change in autonomic symptoms since their last visit. The scoring algorithm of COMPASS was highly complicated and required computer analysis for score generation. COMPASS Change Select score ranged from -150 to 150. A higher score indicated greater autonomic symptom severity.
Measured: Week 48
Change From Baseline in UMSARS Part IV Score at Week 48 in the DBP
The UMSARS part IV comprised a global disability scale ranging from 1-5, with 1 = 'Completely independent. Able to do all chores with minimal difficulty or impairment. Essentially normal. Unaware of any difficulty'; 2 = 'Not completely independent. Needs help with some chores'; 3 = 'More dependent. Help with half of chores. Spends a large part of the day with chores'; 4 = 'Very dependent. Now and then does a few chores alone or begins alone. Much help needed'; and 5 = 'Totally dependent and helpless. Bedridden'. LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Change From Baseline in Speech, Swallowing, Falls, and Walking, as Assessed by the UMSARS Part I Item Scores at Week 48 in the DBP
UMSARS Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks as reported by participants and caregivers (12 items: speech, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function, and bowel function) each rated on a scale ranging from 0 to 4; with 0 = not affected/normal 1= mildly affected/impaired, 2= moderately affected/impaired, 3= severely affected/impaired, and 4 = helpless or entirely affected/impaired. LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Change From Baseline in Number of Falls, as Assessed by the Fall Diary Periods (Weeks 44 to 48) in the DBP
Fall Diary period was defined as the period between the two visits where the diary was filled out according to the protocol. LS mean and SE were calculated using MMRM.
Measured: Baseline, Weeks 44 to 48
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Score at Week 48 in the DBP
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's wellbeing. It consisted of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Percent Change From Baseline in Brain Volume With Ventricles, as Measured by Volumetric MRI (vMRI) at Week 48 in the DBP
LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Percent Change From Baseline in P-Neurofilament Light Chain (NfL) Protein Concentration at Week 48 in the DBP
LS mean and SE were calculated using MMRM.
Measured: Baseline, Week 48
Lu AF82422 Plasma Concentration in the DBP
Measured: Weeks 0, 4, 6, 8, 12, 24, 36, 48, 60, 72, 88
Lu AF82422 Cerebrospinal Fluid (CSF) Concentrations in the DBP
Measured: Weeks 0 and 48
Lu AF82422 CSF/Plasma Concentration Ratio in the DBP
Measured: Weeks 0 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start16 Nov 2021
- Primary completion16 Nov 2023
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104476
- Sponsor's protocol ID
- 18331A
- Acronym
- AMULET
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2021
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kjaersgaard L, Wiedemann J, Singer W, Takeda A, Berger AK, Flensburg MF, Hansen L, Kallunki P, Kompus K, Nighah K, Schmidt SN, Jorgensen MN, Svanholm Fogh B, Zanigni S, Luthman J; AMULET Trial Group. Safety and efficacy of the anti-alpha-synuclein monoclonal antibody amlenetug for the treatment of patients with multiple system atrophy (AMULET): a phase 2, randomised, double-blind, multicentre trial. Lancet Neurol. 2026 Jun;25(6):560-570. doi: 10.1016/S1474-4422(26)00100-6. Epub 2026 Apr 24.
PubMed 42044642
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05104476
- Acronym / sponsor ID
- AMULET / 18331A
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy, Neurodegenerative Disorder, Autonomic Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
Detailed description
This study will consist of a double-blind period (DBP) and will include an optional open-label treatment extension (OLE) period. Participants in the DBP will be randomized to Lu AF82422 or placebo (2:1). All participants entering the OLE will receive Lu AF82422 during the OLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AF82422 | Experimental | Drug: Lu AF82422Participants 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. |
| Placebo | Experimental | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF82422Solution for infusion | Drug | Lu AF82422 |
| PlaceboSolution for infusion | Drug | Placebo |
Primary outcome
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)
Time frame: Baseline up to Week 72
The primary endpoint assessed disease progression by a Bayesian repeated measures model on UMSARS TS. Reported here is the estimated slowing (%) of clinical progression in participants receiving Lu AF82422 relative to those receiving placebo. UMSARS is a combined clinician and patient-reported outcome assessment developed to provide a surrogate measure of disease progression in multiple system atrophy (MSA). UMSARS TS was obtained by the sum of the items from Part I and Part II. Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks and Part II consists of a clinical examination of key MSA motor signs and symptoms. UMSARS TS score was the sum of all items and ranged from 0 (no impairment) to 104 (severe impairment). A higher score indicated greater impairment.
18 secondary outcomes
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP
Time frame: Baseline, Weeks 48 and 72
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP
Time frame: Baseline, Weeks 48 and 72
Change From Baseline in the UMSARS Part I Scores at the EOT DBP
Time frame: Baseline, Weeks 48 and 72
Change From Baseline in the UMSARS Part II Scores at the EOT DBP
Time frame: Baseline, Weeks 48 and 72
Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Total Score at Week 48 in the DBP
Time frame: Week 48
Change From Baseline in UMSARS Part IV Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Change From Baseline in Speech, Swallowing, Falls, and Walking, as Assessed by the UMSARS Part I Item Scores at Week 48 in the DBP
Time frame: Baseline, Week 48
Change From Baseline in Number of Falls, as Assessed by the Fall Diary Periods (Weeks 44 to 48) in the DBP
Time frame: Baseline, Weeks 44 to 48
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Score at Week 48 in the DBP
Time frame: Baseline, Week 48
Percent Change From Baseline in Brain Volume With Ventricles, as Measured by Volumetric MRI (vMRI) at Week 48 in the DBP
Time frame: Baseline, Week 48
Percent Change From Baseline in P-Neurofilament Light Chain (NfL) Protein Concentration at Week 48 in the DBP
Time frame: Baseline, Week 48
Lu AF82422 Plasma Concentration in the DBP
Time frame: Weeks 0, 4, 6, 8, 12, 24, 36, 48, 60, 72, 88
Lu AF82422 Cerebrospinal Fluid (CSF) Concentrations in the DBP
Time frame: Weeks 0 and 48
Lu AF82422 CSF/Plasma Concentration Ratio in the DBP
Time frame: Weeks 0 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42044642Kjaersgaard L, Wiedemann J, Singer W, Takeda A, Berger AK, Flensburg MF, Hansen L, Kallunki P, Kompus K, Nighah K, Schmidt SN, Jorgensen MN, Svanholm Fogh B, Zanigni S, Luthman J; AMULET Trial Group. Safety and efficacy of the anti-alpha-synuclein monoclonal antibody amlenetug for the treatment of patients with multiple system atrophy (AMULET): a phase 2, randomised, double-blind, multicentre trial. Lancet Neurol. 2026 Jun;25(6):560-570. doi: 10.1016/S1474-4422(26)00100-6. Epub 2026 Apr 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AF82422 in people with Multiple System Atrophy, run by H. Lundbeck A/S at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP) (time frame: Baseline up to Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.