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

Study Purpose:

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

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Drug

Intervention Name:

Cu(II)ATSM

Placebo:

No

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

Dominic Rowe, MD, Macquarie University

Clinicaltrials.gov ID:

NCT04313166

Neals Affiliated?

No

Coordinating Center Contact Information

Full Study Summary:

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 Sponsor:

Collaborative Medicinal Development Pty Limited

Estimated Enrollment:

55

Estimated Study Start Date:

03 / 19 / 2020

Estimated Study Completion Date:

02 / 15 / 2022

Posting Last Modified Date:

02 / 17 / 2022

Date Study Added to neals.org:

03 / 18 / 2020

Minimum Age:

18 Years

Maximum Age:

75 Years

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

Macquarie University

Macquarie Park, New South Wales
Australia