Study of ATH434 in Participants With Multiple System Atrophy

• ClinicalTrials.gov Identifier: NCT05109091
• Recruitment Status: Active, not recruiting
• First Posted: November 5, 2021
• Last Update Posted: November 13, 2023
• Sponsor: Alterity Therapeutics
• Information provided by (Responsible Party): Alterity Therapeutics

Tracking Information

• First Submitted Date: October 22, 2021
• First Posted Date: November 5, 2021
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 26, 2021): Change in iron content as measured by brain MRI [ Time Frame: Change from Baseline to Week 52 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 26, 2021)

• Change in Aggregating alpha-Synuclein Levels [ Time Frame: Change from Baseline to Week 52 ]
• Change in Neurofilament Light Chain Levels [ 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 SF-36 Score [ Time Frame: Change from Baseline to Week 52 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of ATH434 in Participants With Multiple System Atrophy
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
• Brief Summary: This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Multiple System Atrophy

Intervention

• Drug: ATH434 dose level 1
  ATH434 taken BID
  Other Name: PBT434
• Drug: ATH434 dose level 2
  ATH434 taken BID
  Other Name: PBT434
• Drug: Placebo
  Placebo taken BID

Study Arms

• Experimental: ATH434 Arm 1
  Intervention: Drug: ATH434 dose level 1
• Experimental: ATH434 Arm 2
  Intervention: Drug: ATH434 dose level 2
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 9, 2023): 77
• Original Estimated Enrollment (submitted: October 26, 2021): 60
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, France, Italy, New Zealand, United Kingdom, United States
• Removed Location Countries: Austria

Administrative Information

• NCT Number: NCT05109091
• Other Study ID Numbers: ATH434-201
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alterity Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Alterity Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Alterity Therapeutics
• Verification Date: November 2023