Study of ATH434 in Participants With Multiple System Atrophy

Alterity Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple System Atrophy

Treatments: Drug: ATH434 dose level 2; Drug: ATH434 dose level 1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05109091

ATH434-201

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 3 patient groups, including a placebo group

ATH434 Arm 1

Experimental group

Treatment:

Drug: ATH434 dose level 1

ATH434 Arm 2

Experimental group

Treatment:

Drug: ATH434 dose level 2

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo