CuATSM Compared With Placebo for Treatment of ALS/MND

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, randomized, double-blind, placebo controlled study to assess the tolerabilty and efficacy of CuATSM in patients with ALS/MND. Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collaborative Medicinal Development Pty Limited

Criteria

Inclusion Criteria:

• signed informed consent

• familial or sporadic ALS/MNS by Awaji-shima Consensus Recommendations

• not taking riluzole or on stable dose of riluzole for 4 weeks prior to screening visit

• no prior exposure to agents other than riluzole for treatment of ALS

• adequate bone marrow reserve, renal and liver function

• women of childbearing potential must have a negative pregnancy test and be non-lactating

• women and men with partners of childbearing potential must take effective contraception while on treatment

Exclusion Criteria:

• presence of a gastrointestinal disorder (eg, malabsorption) that might jeopardize intestinal absorption of study drug

• inability to perform seated SVC

• known immune compromising illness or treatment

• drug abuse or alcoholism

• clinically significant or active cardiovascular disease

• acute or chronic infection

• diagnosis of malignancy within 2 years prior to screening

• dementia that may affect patient understanding and/or compliance with study requirements and procedures

• current use of strong inducers or inhibitors of CYPs 2C19 and 2D6

• current us of medications (other than riluzole) that are metabolized predominantly by CYP 1A2