Study of ATH434 in Participants with Multiple System Atrophy
NCT ID: NCT05109091
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2022-07-01
2024-11-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ATH434 Arm 1
ATH434 dose level 1
ATH434 taken BID
ATH434 Arm 2
ATH434 dose level 2
ATH434 taken BID
Placebo
Placebo
Placebo taken BID
Interventions
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ATH434 dose level 1
ATH434 taken BID
ATH434 dose level 2
ATH434 taken BID
Placebo
Placebo taken BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
75 Years
ALL
No
Sponsors
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Alterity Therapeutics
INDUSTRY
Responsible Party
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Locations
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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 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
CHU/HU Pitié Salpêtrière
Paris, Île-de-France Region, France
IRCCS Istituto Delle Scienze Neurologiche di Bologna
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
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
Countries
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Other Identifiers
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ATH434-201
Identifier Type: -
Identifier Source: org_study_id