NCT04313166

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 19, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

March 15, 2020

Last Update Submit

February 15, 2022

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Treatment-related changes in cognitive function

    24 weeks

  • Treatment-related changed in respiratory function

    SVC

  • Treatment tolerance

    24 weeks

Study Arms (1)

Cu(II)ATSM

EXPERIMENTAL

copper-containing synthetic small molecule

Drug: Cu(II)ATSM

Interventions

Cu(II)ATSMDRUG

cooper-containing synthetic small molecule

Also known as: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
Cu(II)ATSM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not dependent on mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Macquarie University

Macquarie Park, New South Wales, Australia

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

copper (II) diacetyl-di(N(4)-methylthiosemicarbazone)Copper

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Dominic Rowe, MD

    Macquarie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2020

First Posted

March 18, 2020

Study Start

March 19, 2020

Primary Completion

November 18, 2021

Study Completion

February 15, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)