Status:

COMPLETED

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

Lead Sponsor:

Collaborative Medicinal Development Pty Limited

Conditions:

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 si...

Eligibility Criteria

Inclusion

  • 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

  • not dependent on mechanical ventilation

Key Trial Info

Start Date :

March 19 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 15 2022

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT04313166

Start Date

March 19 2020

End Date

February 15 2022

Last Update

February 17 2022

Active Locations (1)

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1

Macquarie University

Macquarie Park, New South Wales, Australia