Amyotrophic Lateral SclerosisPhase 2NCT04313166
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
A Phase 2 study testing Cu(II)ATSM in people with Amyotrophic Lateral Sclerosis, run by Collaborative Medicinal Development Pty Limited at 1 site in Australia.
Trial summary
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Cu(II)ATSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Mar 2020to 15 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not dependent on mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001
Read the detailed description
Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Cu(II)ATSM
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu(II)ATSMDrug
Also called diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
cooper-containing synthetic small molecule
| Study group | Role | What they receive |
|---|---|---|
| Cu(II)ATSM | Experimental | copper-containing synthetic small molecule Receives: Drug: Cu(II)ATSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related changes in disease severity
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
Measured: 24 weeks
Secondary outcomes (3)
Treatment-related changes in cognitive function
Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Measured: 24 weeks
Treatment-related changed in respiratory function
Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
Measured: SVC
Treatment tolerance
Treatment tolerance based on dose reductions and dose terminations due to adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start19 Mar 2020
- Primary completion18 Nov 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collaborative Medicinal Development Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominic Rowe, MD, Principal investigator, Macquarie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313166
- Sponsor's protocol ID
- CMD-2020-001
- Status last verified
- Feb 2022
- First submitted
- 15 Mar 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
- ClinicalTrials.gov ID
- NCT04313166
- Acronym / sponsor ID
- CMD-2020-001
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Collaborative Medicinal Development Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001
Detailed description
Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cu(II)ATSM | Experimental | Drug: Cu(II)ATSMcopper-containing synthetic small molecule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- not dependent on mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cu(II)ATSMAlso: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)cooper-containing synthetic small molecule | Drug | Cu(II)ATSM |
Primary outcome
Treatment-related changes in disease severity
Time frame: 24 weeks
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
3 secondary outcomes
Treatment-related changes in cognitive function
Time frame: 24 weeks
Treatment-related changed in respiratory function
Time frame: SVC
Treatment tolerance
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Rowe, MD principal investigator
Macquarie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cu(II)ATSM in people with Amyotrophic Lateral Sclerosis, run by Collaborative Medicinal Development Pty Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related changes in disease severity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.