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Study of ATH434 in Participants With Multiple System Atrophy

Primary Purpose

Multiple System Atrophy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATH434 dose level 1
ATH434 dose level 2
Placebo
Sponsored by
Alterity Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San DiegoRecruiting
  • University of FloridaRecruiting
  • Rush University Medical CenterRecruiting
  • NorthShore Medical Group - GlenviewRecruiting
  • Johns Hopkins UniversityRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • The Movement Disorder Clinic of OklahomaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • St Vincent's Hospital (Sydney)Recruiting
  • Westmead HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Medizinische Universität InnsbruckRecruiting
  • CHU de Toulouse/Hôpital Pierre-Paul RiquetRecruiting
  • CHU/HU Pitié SalpêtrièreRecruiting
  • CHU de Lille/Hôpital Roger SalengroRecruiting
  • CHU de Marseille/Hôpital de la TimoneRecruiting
  • CHU de Bordeaux/Groupe Hospitalier PellegrinRecruiting
  • IRCCS Istituto Delle Scienze Neurologiche di BolognaRecruiting
  • Policlinico di MilanoRecruiting
  • Azienda Ospedaliero-Universitaria PisanaRecruiting
  • AOU San Giovanni di Dio Ruggi d'AragonaRecruiting
  • New Zealand Brain Research InstituteRecruiting
  • Auckland City HospitalRecruiting
  • University College LondonRecruiting
  • Newcastle UniversityRecruiting
  • Salford Royal HospitalRecruiting
  • Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ATH434 Arm 1

ATH434 Arm 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in iron content as measured by brain MRI

Secondary Outcome Measures

Change in Aggregating alpha-Synuclein Levels
Change in Neurofilament Light Chain Levels
Change in Unified MSA Rating Scale (UMSARS) Score
Change in SF-36 Score

Full Information

First Posted
October 22, 2021
Last Updated
September 12, 2023
Sponsor
Alterity Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05109091
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alterity Therapeutics

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ATH434 Arm 1
Arm Type
Experimental
Arm Title
ATH434 Arm 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ATH434 dose level 1
Other Intervention Name(s)
PBT434
Intervention Description
ATH434 taken BID
Intervention Type
Drug
Intervention Name(s)
ATH434 dose level 2
Other Intervention Name(s)
PBT434
Intervention Description
ATH434 taken BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken BID
Primary Outcome Measure Information:
Title
Change in iron content as measured by brain MRI
Time Frame
Change from Baseline to Week 52
Secondary Outcome Measure Information:
Title
Change in Aggregating alpha-Synuclein Levels
Time Frame
Change from Baseline to Week 52
Title
Change in Neurofilament Light Chain Levels
Time Frame
Change from Baseline to Week 52
Title
Change in Unified MSA Rating Scale (UMSARS) Score
Time Frame
Change from Baseline to Week 52
Title
Change in SF-36 Score
Time Frame
Change from Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has clinical features of parkinsonism. Participant has evidence of orthostatic hypotension and/or bladder dysfunction. Participant has ataxia and/or pyramidal signs on neurological examination. Participant is ambulatory. Participant has biomarker evidence of MSA in biologic fluid and on MRI. Exclusion Criteria: Participant has motor symptoms for > 4 years. Participant has advanced disease, as indicated by frequent falls or choking. Participant has structural brain abnormality on MRI. Participant has any significant neurological disorder other than MSA. Participant has an unstable medical or psychiatric illness. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alterity Clinical Trials
Phone
+1 650 300-2141
Email
ClinicalTrials@alteritytherapeutics.com
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32038
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore Medical Group - Glenview
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
The Movement Disorder Clinic of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital (Sydney)
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tyrol
Country
Austria
Individual Site Status
Recruiting
Facility Name
CHU de Toulouse/Hôpital Pierre-Paul Riquet
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
CHU/HU Pitié Salpêtrière
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Lille/Hôpital Roger Salengro
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Marseille/Hôpital de la Timone
City
Marseille
State/Province
Provence Alpes-Côte d'Azur
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux/Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Delle Scienze Neurologiche di Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico di Milano
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU San Giovanni di Dio Ruggi d'Aragona
City
Salerno
Country
Italy
Individual Site Status
Recruiting
Facility Name
New Zealand Brain Research Institute
City
Christchurch
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital
City
Grafton
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
University College London
City
London
State/Province
England
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle University
City
Newcastle Upon Tyne
State/Province
England
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Salford Royal Hospital
City
Salford
State/Province
England
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Study of ATH434 in Participants With Multiple System Atrophy

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