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Trial record 1 of 1 for:    alterity | MSA - Multiple System Atrophy
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109091
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Alterity Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 78 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 autonomic dysfunction.
  3. Participant has at least one supportive clinical feature of MSA.
  4. Participant is ambulatory.

Exclusion Criteria:

  1. Participant has long duration of motor symptoms.
  2. Participant has advanced disease.
  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.

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


Contacts
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Contact: Alterity Clinical Trials +1 650 300-2141 ClinicalTrials@alteritytherapeutics.com

Locations
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New Zealand
New Zealand Brain Research Institute Recruiting
Christchurch, New Zealand
Auckland City Hospital Recruiting
Grafton, New Zealand
United Kingdom
Salford Royal Hospital Recruiting
Salford, England, United Kingdom
Sponsors and Collaborators
Alterity Therapeutics
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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: August 25, 2022
Last Verified: August 2022

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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
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases