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Completed

NCT Number: NCT04313166

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

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Macquarie University

Macquarie Park, New South Wales, Australia

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cu(II)ATSM

Drug

cooper-containing synthetic small molecule

Other names: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Collaborative Medicinal Development Pty Limited

Industry

Registry information

Official study title

A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 18, 2020
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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