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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Cu(II)ATSM
Sponsored by
Collaborative Medicinal Development Pty Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Macquarie University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cu(II)ATSM

Arm Description

copper-containing synthetic small molecule

Outcomes

Primary Outcome Measures

Treatment-related changes in disease severity
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)

Secondary Outcome Measures

Treatment-related changes in cognitive function
Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Treatment-related changed in respiratory function
Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
Treatment tolerance
Treatment tolerance based on dose reductions and dose terminations due to adverse events

Full Information

First Posted
March 15, 2020
Last Updated
February 15, 2022
Sponsor
Collaborative Medicinal Development Pty Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04313166
Brief Title
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
Official Title
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collaborative Medicinal Development Pty Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cu(II)ATSM
Arm Type
Experimental
Arm Description
copper-containing synthetic small molecule
Intervention Type
Drug
Intervention Name(s)
Cu(II)ATSM
Other Intervention Name(s)
diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
Intervention Description
cooper-containing synthetic small molecule
Primary Outcome Measure Information:
Title
Treatment-related changes in disease severity
Description
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Treatment-related changes in cognitive function
Description
Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Time Frame
24 weeks
Title
Treatment-related changed in respiratory function
Description
Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
Time Frame
SVC
Title
Treatment tolerance
Description
Treatment tolerance based on dose reductions and dose terminations due to adverse events
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Rowe, MD
Organizational Affiliation
Macquarie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macquarie University
City
Macquarie Park
State/Province
New South Wales
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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