Study of ATH434 in Participants with Multiple System Atrophy

Phase 2

Completed

• Conditions: Multiple System Atrophy
• Interventions: Drug: ATH434 dose level 1; Drug: ATH434 dose level 2; Drug: Placebo

• Registration Number: NCT05109091
• Lead Sponsor: Alterity Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Study Start: 2022-07-01
• Primary Completion: 2024-11-28
• Study Completion: 2024-11-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATH434 Arm 1	ATH434 dose level 1	-
ATH434 Arm 2	ATH434 dose level 2	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in iron content as measured by brain MRI	Change from Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change in Neurofilament Light Chain Levels	Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score	Change from Baseline to Week 52
Change in SF-36 Score	Change from Baseline to Week 52

Trial Locations

Locations (23)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

The Movement Disorder Clinic of Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

St Vincent's Hospital (Sydney); 🇦🇺 Darlinghurst, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

CHU/HU Pitié Salpêtrière; 🇫🇷 Paris, Ile-de-France, France

CHU de Toulouse/Hôpital Pierre-Paul Riquet; 🇫🇷 Toulouse, Haute-Garonne, France

CHU de Bordeaux/Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

CHU de Marseille/Hôpital de la Timone; 🇫🇷 Marseille, France

Auckland City Hospital; 🇳🇿 Grafton, New Zealand

University College London; 🇬🇧 London, England, United Kingdom

Newcastle University; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom

Salford Royal Hospital; 🇬🇧 Salford, England, United Kingdom

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom

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, Italy

New Zealand Brain Research Institute; 🇳🇿 Christchurch, New Zealand