CuATSM Compared With Placebo for Treatment of ALS/MND

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment. Study drug is administered orally, once a day in fasted state (before breakfast). Assessments for safety (physical examination, vital signs, hematology, serum chemistry adverse events) will be conducted at baseline and following each cycle of treatment. Assessments for efficacy (Revised ALS Functional Rating Scale [ASLFRS-R] score, and Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen [ECAS] score, and seated slow vital capacity [SVC]) will be conducted at baseline and following 2, 4 and 6 cycles of treatment. Analysis of covariance (ANCOVA) will be used to compare efficacy endpoints between CuATSM and placebo groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04082832
Study type	Interventional
Source	Collaborative Medicinal Development Pty Limited
Contact	Kay Noel, PhD
Phone	(415) 444 9600
Email	Kay.Noel@colMedDev.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 30, 2019
Completion date	December 30, 2020

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