Study of ATH434 in Participants With Multiple System Atrophy

Multiple System Atrophy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05109091
• Other study ID #: ATH434-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Alterity Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Drug:
• ATH434 dose level 1
ATH434 taken BID
• ATH434 dose level 2
ATH434 taken BID
• Placebo
Placebo taken BID

Locations

Country	Name	City	State
Australia	St Vincent's Hospital (Sydney)	Darlinghurst	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
France	CHU de Bordeaux/Groupe Hospitalier Pellegrin	Bordeaux
France	CHU de Marseille/Hôpital de la Timone	Marseille	Provence Alpes-Côte d'Azur
France	CHU/HU Pitié Salpêtrière	Paris	Ile-de-France
France	CHU de Toulouse/Hôpital Pierre-Paul Riquet	Toulouse	Haute-Garonne
Italy	IRCCS Istituto Delle Scienze Neurologiche di Bologna	Bologna
Italy	Policlinico di Milano	Milan
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	AOU San Giovanni di Dio Ruggi d'Aragona	Salerno
New Zealand	New Zealand Brain Research Institute	Christchurch
New Zealand	Auckland City Hospital	Grafton
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Scotland
United Kingdom	University College London	London	England
United Kingdom	Newcastle University	Newcastle Upon Tyne	England
United Kingdom	Salford Royal Hospital	Salford	England
United States	Johns Hopkins University	Baltimore	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	University of California San Diego	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Irving Medical Center	New York	New York
United States	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Alterity Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in iron content as measured by brain MRI		Change from Baseline to Week 52
Secondary	Change in Aggregating alpha-Synuclein Levels		Change from Baseline to Week 52
Secondary	Change in Neurofilament Light Chain Levels		Change from Baseline to Week 52
Secondary	Change in Unified MSA Rating Scale (UMSARS) Score		Change from Baseline to Week 52
Secondary	Change in SF-36 Score		Change from Baseline to Week 52