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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313166
Recruitment Status : Completed
First Posted : March 18, 2020
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Collaborative Medicinal Development Pty Limited

Study Description
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Brief Summary:
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Cu(II)ATSM Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
Actual Study Start Date : March 19, 2020
Actual Primary Completion Date : November 18, 2021
Actual Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cu(II)ATSM
copper-containing synthetic small molecule
 Drug: Cu(II)ATSM
cooper-containing synthetic small molecule
Other Name: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Treatment-related changes in cognitive function [ Time Frame: 24 weeks ]
    Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score

  2. Treatment-related changed in respiratory function [ Time Frame: SVC ]
    Treatment-related changes in respiratory function by seated slow vital capacity (SVC)

  3. Treatment tolerance [ Time Frame: 24 weeks ]
    Treatment tolerance based on dose reductions and dose terminations due to adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313166


Locations
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Australia, New South Wales
Macquarie University
Macquarie Park, New South Wales, Australia
Sponsors and Collaborators
Collaborative Medicinal Development Pty Limited
Investigators
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Principal Investigator: Dominic Rowe, MD Macquarie University
More Information
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Responsible Party: Collaborative Medicinal Development Pty Limited
ClinicalTrials.gov Identifier: NCT04313166    
Other Study ID Numbers: CMD-2020-001
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Copper
Trace Elements
Micronutrients
Physiological Effects of Drugs