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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03136809




Registration number
NCT03136809
Ethics application status
Date submitted
28/04/2017
Date registered
2/05/2017

Titles & IDs
Public title
ALS Treatment Extension Study
Scientific title
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Completed Study CMD-2016-001
Secondary ID [1] 0 0
CMD-2017-001
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 - Cu(II)ATSM administered once daily


Treatment: Drugs: Cu(II)ATSM
copper-containing synthetic small molecule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tolerance of extended treatment
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Treatment-related change in disease severity by ALS Functional Rating Scale - Revised (ALSFRS-R)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Treatment-related change in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Treatment-related change in respiratory function by seated forced vital capacity (FVC)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Treatment-related change in quality of life by ALSSQOL-R score
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Treatment-related change in respiratory function by sniff nasal pressure (SNP) test
Timepoint [5] 0 0
24 months

Eligibility
Key inclusion criteria
* Signed informed consent prior to initiation of any study-specific procedures and treatment
* Documented completion of protocol-specific assessments following completion of six 28-day treatment cycles in study CMD-2016-001
* Principal Investigator considers the patient would benefit from continued treatment with Cu(II)ATSM
* Not taking riluzole or on the same (or lower) dose used during the CMD-2016-001 study
* Adequate bone marrow reserve, renal and liver function
* Women and men with partners of childbearing potential must take effective contraception while on study treatment
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to swallow oral medications or presence of a gastrointestinal disorder (e.g.,malabsorption) deemed to jeopardize intestinal absorption of study drug
* Dependence on mechanical ventilation (invasive or non-invasive) for any part of day or night, where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use
* Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
* Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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)?
Yes
What data in particular will be shared?
Plan to publish study results in a peer-reviewed journal
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT03136809