CompletedPhase 2
Study of ATH434 in Participants with Multiple System Atrophy
Key facts
- Who runs it
- Alterity Therapeutics
- Where
- Baltimore, Chicago, La Jolla, Nashville, New York, and Tulsa, United StatesSee the 6 sitesAlso in 5 other countries, 17 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 77 people enrolled
- Started
- 1 Jul 2022
- Ended
- 28 Nov 2024
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ATH434 dose level 1
- ATH434 dose level 2
- Placebo
- Record updated
- 13 December 2024
Who can take part
- Age
- 30 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participant has advanced disease, as indicated by frequent falls or choking
- Participant has any significant neurological disorder other than MSA
- Participant has an unstable medical or psychiatric illness
- Participant has motor symptoms for > 4 years
- Participant has structural brain abnormality on MRI
- Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture
Where in United States
Also in 5 other countries, 17 sites
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- University of California San DiegoLa Jolla, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- The Movement Disorder Clinic of OklahomaTulsa, United StatesNo longer taking part
About the trial
What the trial wants to find out
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy
The 3 groups in the trial
- ATH434 Arm 1Treatment being tested
Treatment: ATH434 dose level 1
- ATH434 Arm 2Treatment being tested
Treatment: ATH434 dose level 2
- PlaceboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
- Record updated
- 13 December 2024