ALS Treatment Extension Study

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03136809
Study type	Interventional
Source	Collaborative Medicinal Development Pty Limited
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	January 18, 2018
Completion date	December 31, 2022

View Details

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