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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04313166
Registration number
NCT04313166
Ethics application status
Date submitted
15/03/2020
Date registered
18/03/2020
Date last updated
17/02/2022
Titles & IDs
Public title
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
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Scientific title
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
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Secondary ID [1]
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CMD-2020-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis
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Condition category
Condition code
Neurological
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Neurodegenerative diseases
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cu(II)ATSM
Experimental: Cu(II)ATSM - copper-containing synthetic small molecule
Treatment: Drugs: Cu(II)ATSM
cooper-containing synthetic small molecule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment-related changes in disease severity
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Assessment method [1]
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Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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Treatment-related changes in cognitive function
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Assessment method [1]
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Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Treatment-related changed in respiratory function
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Assessment method [2]
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Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
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Timepoint [2]
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SVC
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Secondary outcome [3]
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Treatment tolerance
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Assessment method [3]
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Treatment tolerance based on dose reductions and dose terminations due to adverse events
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Timepoint [3]
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24 weeks
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Eligibility
Key inclusion criteria
- signed informed consent prior to initiation of any study-specific procedures and
treatment
- documented completion of protocol-specified assessments following completion of 24
weeks treatment on study CMD-2019-002
- Investigator considers patient has been tolerating treatment on study CMD-2019-001 and
may benefit from continued treatment with CuATSM
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- not dependent on mechanical ventilation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/02/2022
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Macquarie University - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Collaborative Medicinal Development Pty Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Provides up to six months treatment with CuATSM for subjects who have successfully completed
study CMD-2019-001
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04313166
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dominic Rowe, MD
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Address
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Macquarie University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04313166
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