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