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Trial record 1 of 2 for:    ath434
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Biomarker Study of ATH434 in Participants With MSA

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: NCT05864365
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2023
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Alterity Therapeutics

Tracking Information
First Submitted Date  ICMJE May 9, 2023
First Posted Date  ICMJE May 18, 2023
Last Update Posted Date February 7, 2024
Actual Study Start Date  ICMJE May 23, 2023
Estimated Primary Completion Date February 14, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2023)		 Change in iron content as measured by brain MRI [ Time Frame: Change from Baseline to Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2023)
  • 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 36-Item Short Form Survey (SF-36) Score [ Time Frame: Change from Baseline to Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker Study of ATH434 in Participants With MSA
Official Title  ICMJE An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
Brief Summary This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple System Atrophy
Intervention  ICMJE Drug: ATH434
ATH434 taken by mouth two times per day
Study Arms  ICMJE Experimental: ATH434
Intervention: Drug: ATH434
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 9, 2023)		 15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2025
Estimated Primary Completion Date February 14, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

  1. Participant is unable to swallow study drug.
  2. Participant is unable to attend study visits or complete study procedures.
  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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05864365
Other Study ID Numbers  ICMJE ATH434-202
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  ICMJE Not Provided
Current Responsible Party Alterity Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alterity Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alterity Therapeutics
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP