ALS Treatment Extension Study

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collaborative Medicinal Development Pty Limited
• Treatments: Copper

Criteria

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