Multiple System AtrophyNCT07531433
Post-Trial Access to ATH434 for Patients With Multiple System Atrophy
A study testing ATH434 in people with Multiple System Atrophy, run by Alterity Therapeutics.
Trial summary
This multicenter post-trial access program is designed to provide ATH434 orally BID to eligible patients who completed Phase 2 studies ATH434-201 or ATH434-202, and who may benefit from this treatment according to the evaluation by their treating physicians. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- ATH434
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Completed Alterity protocol ATH434-201 or ATH434-202
- Expected to benefit from treatment from treatment with ATH434, in the opinion of the treating physician
Who cannot join
- Discontinued prior ATH434 treatment (ATH434-201 or ATH434-202) for any reason
- Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the treating physician's opinion
Trial locations and contacts
No sites are listed yet.
About this study
This multicenter post-trial access program is designed to provide ATH434 orally BID to eligible patients who completed Phase 2 studies ATH434-201 or ATH434-202, and who may benefit from this treatment according to the evaluation by their treating physicians.
Read the detailed description
This multicenter PTA program is designed to provide ATH434 orally BID to eligible patients who have completed the ATH434-201 or ATH434-202 Phase 2 clinical trials, and who may benefit from this treatment according to evaluation by their treating physician. Up to 20 patients will be enrolled in the US.
For each patient, treating physicians will request participation in the PTA study and initial ATH434 shipment for patients who meet entry criteria. Upon review and approval by the Medical Monitor/Sponsor, treating physicians will obtain informed consent from the patient and proceed with ATH434 initiation under the PTA program. Pertinent documented medical information will be requested to confirm eligibility and assess patient safety throughout the PTA program.
Eligible patients will receive ATH434 tablets BID to be taken with food for up to 12 months, and will complete in-clinic and remote visits for safety and to dispense/return ATH434.
- Conditions
- Multiple System Atrophy
- Being tested
- ATH434
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH434Drug
Also called PBT434
ATH434 tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Alterity Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531433
- Sponsor's protocol ID
- ATH434-901
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Trial Access to ATH434 for Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07531433
- Acronym / sponsor ID
- ATH434-901
- Conditions
- Multiple System Atrophy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Alterity TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 15 Apr 2026 (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 multicenter post-trial access program is designed to provide ATH434 orally BID to eligible patients who completed Phase 2 studies ATH434-201 or ATH434-202, and who may benefit from this treatment according to the evaluation by their treating physicians.
Detailed description
This multicenter PTA program is designed to provide ATH434 orally BID to eligible patients who have completed the ATH434-201 or ATH434-202 Phase 2 clinical trials, and who may benefit from this treatment according to evaluation by their treating physician. Up to 20 patients will be enrolled in the US.
For each patient, treating physicians will request participation in the PTA study and initial ATH434 shipment for patients who meet entry criteria. Upon review and approval by the Medical Monitor/Sponsor, treating physicians will obtain informed consent from the patient and proceed with ATH434 initiation under the PTA program. Pertinent documented medical information will be requested to confirm eligibility and assess patient safety throughout the PTA program.
Eligible patients will receive ATH434 tablets BID to be taken with food for up to 12 months, and will complete in-clinic and remote visits for safety and to dispense/return ATH434.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed Alterity protocol ATH434-201 or ATH434-202
- Expected to benefit from treatment from treatment with ATH434, in the opinion of the treating physician
Key exclusion criteria (2 listed)
- Discontinued prior ATH434 treatment (ATH434-201 or ATH434-202) for any reason
- Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the treating physician's opinion
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 |
|---|---|---|
| ATH434Also: PBT434ATH434 tablets | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ATH434 in people with Multiple System Atrophy, run by Alterity Therapeutics.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alterity Clinical Trials (888-556-7582, clinicaltrials@alteritytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Apr 2026.