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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05109091


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05109091
Ethics application status
Date submitted
22/10/2021
Date registered
5/11/2021

Titles & IDs
Public title
Study of ATH434 in Participants with Multiple System Atrophy
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
Secondary ID [1] 0 0
ATH434-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple System Atrophy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATH434 dose level 1
Treatment: Drugs - ATH434 dose level 2
Treatment: Drugs - Placebo

Experimental: ATH434 Arm 1 -

Experimental: ATH434 Arm 2 -

Placebo comparator: Placebo -


Treatment: Drugs: ATH434 dose level 1
ATH434 taken BID

Treatment: Drugs: ATH434 dose level 2
ATH434 taken BID

Treatment: Drugs: Placebo
Placebo taken BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in iron content as measured by brain MRI
Timepoint [1] 0 0
Change from Baseline to Week 52
Secondary outcome [1] 0 0
Change in Neurofilament Light Chain Levels
Timepoint [1] 0 0
Change from Baseline to Week 52
Secondary outcome [2] 0 0
Change in Unified MSA Rating Scale (UMSARS) Score
Timepoint [2] 0 0
Change from Baseline to Week 52
Secondary outcome [3] 0 0
Change in SF-36 Score
Timepoint [3] 0 0
Change from Baseline to Week 52

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2024
Sample size
Target
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital (Sydney) - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
France
State/province [7] 0 0
Haute-Garonne
Country [8] 0 0
France
State/province [8] 0 0
Ile-de-France
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
Italy
State/province [11] 0 0
Bologna
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Pisa
Country [14] 0 0
Italy
State/province [14] 0 0
Salerno
Country [15] 0 0
New Zealand
State/province [15] 0 0
Christchurch
Country [16] 0 0
New Zealand
State/province [16] 0 0
Grafton
Country [17] 0 0
United Kingdom
State/province [17] 0 0
England
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alterity Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05109091

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,VIC
Recruiting in New Zealand
Province(s)/district(s)
Canterbury, Auckland
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
 
Public notes

Contacts
Principal investigator
Title 341 0
Name 341 0
Address 341 0
Country 341 0
Phone 341 0
Fax 341 0
Email 341 0
Contact person for public queries
Title 342 0
Name 342 0
Address 342 0
Country 342 0
Phone 342 0
Fax 342 0
Email 342 0
Contact person for scientific queries
Title 343 0
Name 343 0
Address 343 0
Country 343 0
Phone 343 0
Fax 343 0
Email 343 0