Treatment Continuation Study for Patients With ALS/MND Wh... | NCT04313166

Studies
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

NCT04313166

Sponsor

Collaborative Medicinal Development Pty Limited

Status

Completed

Last Update Posted

Feb 17, 2022Actual

Enrollment

55Actual

Phase

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Cu(II)ATSM

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2020Actual

Primary Completion Date

Nov 18, 2021Actual

Completion Date

Feb 15, 2022Actual

First Submitted Date

Mar 15, 2020

First Submission Date that Met QC Criteria

Mar 15, 2020

First Posted Date

Mar 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Feb 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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]

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cu(II)ATSM	Experimental	copper-containing synthetic small molecule	Drug: Cu(II)ATSM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cu(II)ATSM	Drug	cooper-containing synthetic small molecule	Cu(II)ATSM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment-related changes in disease severity	Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Treatment-related changes in cognitive function	Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score	24 weeks
Treatment-related changed in respiratory function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

not dependent on mechanical ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominic Rowe, MD	Macquarie University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Macquarie University		Macquarie Park	New South Wales		Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C089548	copper (II) diacetyl-di(N(4)-methylthiosemicarbazone)
D003300	Copper

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided