Multiple System AtrophyPhase 2NCT05864365
A Biomarker Study of ATH434 in Participants With MSA
A Phase 2 study testing ATH434 in people with Multiple System Atrophy, run by Alterity Therapeutics at 1 site in United States.
Trial summary
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- ATH434
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 26 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 has biomarker evidence of MSA in biologic fluid and on MRI.
Who cannot join
- Participant is unable to swallow study drug.
- Participant is unable to attend study visits or complete study procedures.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
- Conditions
- Multiple System Atrophy
- Being tested
- ATH434
- Keywords
- Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism, Biomarkers
- Medical subject headings
- Multiple System Atrophy, Neurodegenerative Diseases, Shy-Drager Syndrome, Movement Disorders, Primary Dysautonomias, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH434Drug
ATH434 taken by mouth two times per day
| Study group | Role | What they receive |
|---|---|---|
| ATH434 | Experimental | Not described Receives: Drug: ATH434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain volume as measured by MRI
Measured: Change from Baseline to Week 52
Secondary outcomes (5)
Change in iron content in substantia nigra as measured by MRI
Measured: Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Measured: Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)
Measured: Change from Baseline to Week 52
Change in Clinical Global Impression of Change (CGI-C)
Measured: Change from Baseline to Week 52
Change in Neurofilament Light Chain Levels
Measured: Change from Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start23 May 2023
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alterity Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864365
- Sponsor's protocol ID
- ATH434-202
- Status last verified
- Mar 2025
- First submitted
- 9 May 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT05864365
- Acronym / sponsor ID
- ATH434-202
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alterity TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATH434 | Experimental | Drug: ATH434 |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 has biomarker evidence of MSA in biologic fluid and on MRI.
Key exclusion criteria (6 listed)
- Participant is unable to swallow study drug.
- Participant is unable to attend study visits or complete study procedures.
- Participant has structural brain abnormality on MRI.
- Participant has any significant neurological disorder other than MSA.
- Participant has an unstable medical or psychiatric illness.
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 |
|---|---|---|
| ATH434ATH434 taken by mouth two times per day | Drug | ATH434 |
Primary outcome
Change in brain volume as measured by MRI
Time frame: Change from Baseline to Week 52
5 secondary outcomes
Change in iron content in substantia nigra as measured by MRI
Time frame: Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Time frame: Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)
Time frame: Change from Baseline to Week 52
Change in Clinical Global Impression of Change (CGI-C)
Time frame: Change from Baseline to Week 52
Change in Neurofilament Light Chain Levels
Time frame: Change from Baseline to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATH434 in people with Multiple System Atrophy, run by Alterity Therapeutics at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in brain volume as measured by MRI (time frame: Change from Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.