Trial · NCT05104476

A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476, Phase 2, Active not recruiting, H. Lundbeck A/S; results first posted 2024-12-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Lu AF82422 in Participants With Multiple System Atrophy. Trials, record NCT05104476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05104476

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Lu AF82422 in Participants With Multiple System Atrophy
NCT number: NCT05104476
Status: Active not recruiting
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: H. Lundbeck A/S
Conditions: Multiple System Atrophy
Interventions: Lu AF82422, Placebo
First posted: 2021-11-03
Last updated: 2026-04-13
Results first posted: 2024-12-27

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)	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.
Secondary	Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Baseline, Weeks 48 and 72	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.
Secondary	Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Baseline, Weeks 48 and 72	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.
Secondary	Change From Baseline in the UMSARS Part I Scores at the EOT DBP	Baseline, Weeks 48 and 72	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.
Secondary	Change From Baseline in the UMSARS Part II Scores at the EOT DBP	Baseline, Weeks 48 and 72	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.
Secondary	Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP	Baseline, Week 48	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.
Secondary	Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP	Baseline, Week 48	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.
Secondary	Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 in the DBP	Baseline, Week 48	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.
Secondary	Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 in the DBP	Baseline, Week 48	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.
Secondary	Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Total Score at Week 48 in the DBP	Week 48	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.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)	Baseline up to Week 72	Full analysis set (FAS) included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment.	Percentage Slowing of Clin. Progression	NUMBER
SECONDARY	Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Baseline, Weeks 48 and 72	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Baseline, Weeks 48 and 72	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the UMSARS Part I Scores at the EOT DBP	Baseline, Weeks 48 and 72	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the UMSARS Part II Scores at the EOT DBP	Baseline, Weeks 48 and 72	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP	Baseline, Week 48	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP	Baseline, Week 48	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 in the DBP	Baseline, Week 48	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 in the DBP	Baseline, Week 48	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Total Score at Week 48 in the DBP	Week 48	FAS included all randomized participants who received at least 1 dose of double-blind IMP and had a valid baseline assessment and at least 1 valid post-baseline assessment of the UMSARS TS, prior to, or at withdrawal from treatment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)	Lu AF82422 or Placebo		19		Percentage Slowing of Clin. Progression
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Placebo	Change at Week 48	13.93	Standard Error 3.42	units on a scale
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Lu AF82422	Change at Week 48	13.32	Standard Error 2.86	units on a scale
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Placebo	Change at Week 72	19.13	Standard Error 3.74	units on a scale
Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP	Lu AF82422	Change at Week 72	15.10	Standard Error 3.00	units on a scale
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Placebo	Change at Week 48	7.07	Standard Error 1.62	units on a scale
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Lu AF82422	Change at Week 48	6.48	Standard Error 1.33	units on a scale
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Placebo	Change at Week 72	8.40	Standard Error 2.00	units on a scale
Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP	Lu AF82422	Change at Week 72	8.77	Standard Error 1.44	units on a scale
Change From Baseline in the UMSARS Part I Scores at the EOT DBP	Placebo	Change at Week 48	7.64	Standard Error 1.92	units on a scale

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	22
Overall Study	STARTED	Lu AF82422	42
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	21
Overall Study	Received at Least 1 Dose of Study Drug	Lu AF82422	40
Overall Study	COMPLETED	Placebo	16
Overall Study	COMPLETED	Lu AF82422	32
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Lu AF82422	10

Source ClinicalTrials.gov

Adverse events104

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Placebo	0	21	0
other	Constipation	Gastrointestinal disorders	Lu AF82422	2	40	2
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Placebo	2	21	2
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Lu AF82422	0	40	0
other	Nausea	Gastrointestinal disorders	Placebo	1	21	1
other	Nausea	Gastrointestinal disorders	Lu AF82422	3	40	3
other	Chest pain	General disorders	Placebo	0	21	0
other	Chest pain	General disorders	Lu AF82422	2	40	2
other	Fatigue	General disorders	Placebo	2	21	2
other	Fatigue	General disorders	Lu AF82422	3	40	3

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	21
Total, all-cause mortality	Lu AF82422	2	40
Total, other adverse events	Placebo	14	21
Total, other adverse events	Lu AF82422	34	40
Total, serious adverse events	Placebo	7	21
Total, serious adverse events	Lu AF82422	12	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42044642	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lu AF82422 vs Placebo: deaths from any cause	Trial comparisons
Lu AF82422 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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