COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04313166




Registration number
NCT04313166
Ethics application status
Date submitted
15/03/2020
Date registered
18/03/2020
Date last updated
18/03/2020

Titles & IDs
Public title
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
Scientific title
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
Secondary ID [1] 0 0
CMD-2020-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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

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

Outcomes
Primary outcome [1] 0 0
Treatment-related changes in disease severity - Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Treatment-related changes in cognitive function - Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Treatment-related changed in respiratory function - Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
Timepoint [2] 0 0
SVC
Secondary outcome [3] 0 0
Treatment tolerance - Treatment tolerance based on dose reductions and dose terminations due to adverse events
Timepoint [3] 0 0
24 weeks

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- not dependent on mechanical ventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Collaborative Medicinal Development Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Provides up to six months treatment with CuATSM for subjects who have successfully completed
study CMD-2019-001
Trial website
https://clinicaltrials.gov/show/NCT04313166
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dominic Rowe, MD
Address 0 0
Macquarie University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kay Noel, PhD
Address 0 0
Country 0 0
Phone 0 0
5108152575
Fax 0 0
Email 0 0
kay.noel@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04313166