A Study of Lu AF82422 in Participants With Multiple System Atrophy (NCT05104476) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Lu AF82422 in Participants With Multiple System Atrophy
United States64 participantsStarted 2021-11-16
Plain-language summary
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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 histor…
What they're measuring
1
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)