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Study of ATH434 in Participants With Multiple System Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109091
Recruitment Status : Active, not recruiting
First Posted : November 5, 2021
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Alterity Therapeutics

Study Description
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Brief Summary:
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: ATH434 dose level 1 Drug: ATH434 dose level 2 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ATH434 Arm 1 Drug: ATH434 dose level 1
ATH434 taken BID
Other Name: PBT434
Experimental: ATH434 Arm 2 Drug: ATH434 dose level 2
ATH434 taken BID
Other Name: PBT434
Placebo Comparator: Placebo Drug: Placebo
Placebo taken BID


Outcome Measures
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Primary Outcome Measures :
  1. Change in iron content as measured by brain MRI [ Time Frame: Change from Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Change in Aggregating alpha-Synuclein Levels [ Time Frame: Change from Baseline to Week 52 ]
  2. Change in Neurofilament Light Chain Levels [ Time Frame: Change from Baseline to Week 52 ]
  3. Change in Unified MSA Rating Scale (UMSARS) Score [ Time Frame: Change from Baseline to Week 52 ]
  4. Change in SF-36 Score [ Time Frame: Change from Baseline to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109091


Locations
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Sponsors and Collaborators
Alterity Therapeutics
More Information
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Responsible Party: Alterity Therapeutics
ClinicalTrials.gov Identifier: NCT05109091    
Other Study ID Numbers: ATH434-201
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alterity Therapeutics:
Multiple System Atrophy
ATH434
Neurodegenerative disease
Shy-Drager Syndrome
 Movement disorders
Autonomic dysfunction
Synucleinopathies
Atypical parkinsonism
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases