Study Purpose:
Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Cu(II)ATSM
Placebo:
No
Phase:
Phase 1/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:
Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment. The same safety assessments as in the CMD-2016-001 study will be conducted after each cycle of treatment and the same efficacy assessments as in the CMD-2016-001 study will be conducted after every 3 cycles of treatment. Treatment will continue until the first to occur of (1) Investigator considers the patient is no longer deriving benefit from CuATSM treatment, (2) patient develops dependence on mechanical ventilation where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use, or (3) the patient withdraws consent.
Study Sponsor:
Collaborative Medicinal Development Pty Limited
Participant Duration:
24 months
Estimated Enrollment:
28
Estimated Study Start Date:
01 / 18 / 2018
Estimated Study Completion Date:
12 / 31 / 2022
Posting Last Modified Date:
02 / 17 / 2022
Date Study Added to neals.org:
05 / 02 / 2017
Minimum Age:
18 Years
Maximum Age:
75 Years
Can participants use Riluzole?
Yes
Inclusion Criteria:- Signed informed consent prior to initiation of any study-specific procedures and treatment
- Documented completion of protocol-specific assessments following completion of six 28-day treatment cycles in study CMD-2016-001
- Principal Investigator considers the patient would benefit from continued treatment with Cu(II)ATSM
- Not taking riluzole or on the same (or lower) dose used during the CMD-2016-001 study
- Adequate bone marrow reserve, renal and liver function
- Women and men with partners of childbearing potential must take effective contraception while on study treatment
Exclusion Criteria:
- Inability to swallow oral medications or presence of a gastrointestinal disorder (e.g.,malabsorption) deemed to jeopardize intestinal absorption of study drug
- Dependence on mechanical ventilation (invasive or non-invasive) for any part of day or night, where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use
- Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
- Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6
Macquarie University
Sydney, New South Wales
2109
Australia