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ATH434 dose level 1

Phase 2

Multiple System Atrophy | Small molecule | Neurology |Alterity Therapeutics Limited|Last Updated: Dec 13, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

ATH434 dose level 1 · 1 trial · 1 indication

Phase 2 1
NCT05109091Study of ATH434 in Participants with Multiple System AtrophyMultiple System Atrophy
COMPLETED77 Analytics
PHASE2COMPLETED
Study of ATH434 in Participants with Multiple System Atrophy
Multiple System AtrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in iron content as measured by brain MRI
Change from Baseline to Week 52

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATH434 Arm 1EXPERIMENTAL -
ATH434 Arm 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ATH434 dose level 1DRUGATH434 taken BID
ATH434 dose level 2DRUGATH434 taken BID
PlaceboDRUGPlacebo taken BID
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites23

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 evide...

Countries:United StatesAustraliaFranceItalyNew ZealandUnited Kingdom
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Frequently asked questions about ATH434 dose level 1

What is ATH434 dose level 1 used for in Multiple System Atrophy?

ATH434 dose level 1 is an investigational small molecule being studied for the treatment of Multiple System Atrophy (MSA), a rare neurological disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its potential to slow disease progression in patients with MSA.

What does ATH434 dose level 1 target?

The specific molecular target of ATH434 dose level 1 has not been disclosed in the available information. The drug is a small molecule being investigated for its effects in Multiple System Atrophy, but its precise mechanism of action is not publicly detailed at this time.

Who makes ATH434 dose level 1?

ATH434 dose level 1 is being developed by Alterity Therapeutics Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ATHE. The company is conducting clinical research on this investigational drug for the treatment of Multiple System Atrophy.

What phase is ATH434 dose level 1 in?

ATH434 dose level 1 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Orphan Drug and Fast Track designations by the FDA for the treatment of Multiple System Atrophy.

What clinical trials is ATH434 dose level 1 in?

ATH434 dose level 1 was studied in a Phase 2 clinical trial with the identifier NCT05109190, titled 'Study of ATH434 in Participants with Multiple System Atrophy'. This randomized, double-blind, placebo-controlled trial enrolled 77 participants and has been completed. The trial was conducted in the United States, Australia, France, Italy, New Zealand, and the United Kingdom.

Is ATH434 dose level 1 the same as ATH434?

ATH434 dose level 1 is a specific dose level of the investigational drug ATH434. The drug is being developed by Alterity Therapeutics for Multiple System Atrophy. The Phase 2 trial NCT05109190 evaluated ATH434 at this dose level, and the drug has received Orphan Drug and Fast Track designations from the FDA.