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Study of ATH434 in Participants with Multiple System Atrophy

Phase 2
Completed
Conditions
Multiple System Atrophy
Interventions
Drug: ATH434 dose level 1
Drug: ATH434 dose level 2
Drug: Placebo
Registration Number
NCT05109091
Lead Sponsor
Alterity Therapeutics
Brief Summary

This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
77
Inclusion Criteria
  1. Participant has clinical features of parkinsonism.
  2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
  3. Participant has ataxia and/or pyramidal signs on neurological examination.
  4. Participant is ambulatory.
  5. Participant has biomarker evidence of MSA in biologic fluid and on MRI.
Exclusion Criteria
  1. Participant has motor symptoms for > 4 years.
  2. Participant has advanced disease, as indicated by frequent falls or choking.
  3. Participant has structural brain abnormality on MRI.
  4. Participant has any significant neurological disorder other than MSA.
  5. Participant has an unstable medical or psychiatric illness.
  6. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ATH434 Arm 1ATH434 dose level 1-
ATH434 Arm 2ATH434 dose level 2-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Change in iron content as measured by brain MRIChange from Baseline to Week 52
Secondary Outcome Measures
NameTimeMethod
Change in Neurofilament Light Chain LevelsChange from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) ScoreChange from Baseline to Week 52
Change in SF-36 ScoreChange from Baseline to Week 52

Trial Locations

Locations (23)

University of California San Diego

🇺🇸

La Jolla, California, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

Columbia University Irving Medical Center

🇺🇸

New York, New York, United States

The Movement Disorder Clinic of Oklahoma

🇺🇸

Tulsa, Oklahoma, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

St Vincent's Hospital (Sydney)

🇦🇺

Darlinghurst, New South Wales, Australia

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

CHU de Toulouse/Hôpital Pierre-Paul Riquet

🇫🇷

Toulouse, Haute-Garonne, France

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University of California San Diego
🇺🇸La Jolla, California, United States

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