Study of ATH434 in Participants with Multiple System Atrophy
- Conditions
- Multiple System Atrophy
- Interventions
- Drug: ATH434 dose level 1Drug: ATH434 dose level 2Drug: 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
- Participant has clinical features of parkinsonism.
- Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
- Participant has ataxia and/or pyramidal signs on neurological examination.
- Participant is ambulatory.
- Participant has biomarker evidence of MSA in biologic fluid and on MRI.
- Participant has motor symptoms for > 4 years.
- Participant has advanced disease, as indicated by frequent falls or choking.
- Participant has structural brain abnormality on MRI.
- Participant has any significant neurological disorder other than MSA.
- Participant has an unstable medical or psychiatric illness.
- Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATH434 Arm 1 ATH434 dose level 1 - ATH434 Arm 2 ATH434 dose level 2 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in iron content as measured by brain MRI Change from Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Change in Neurofilament Light Chain Levels Change from Baseline to Week 52 Change in Unified MSA Rating Scale (UMSARS) Score Change from Baseline to Week 52 Change in SF-36 Score Change 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
Scroll for more (13 remaining)University of California San Diego🇺🇸La Jolla, California, United States