Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

Collaborative Medicinal Development Pty Limited55 enrolled

Overview

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. \[This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001\]

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Cu(II)ATSMDRUG

cooper-containing synthetic small molecule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * signed informed consent prior to initiation of any study-specific procedures and treatment * documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002 * Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM Exclusion Criteria: * not dependent on mechanical ventilation

Locations (1)

Macquarie University

Macquarie Park, New South Wales, Australia

Outcomes

Primary Outcomes

Treatment-related changes in disease severity

Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)

Time frame: 24 weeks

Secondary Outcomes

Treatment-related changes in cognitive function

Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score

Time frame: 24 weeks

Treatment-related changed in respiratory function

Treatment-related changes in respiratory function by seated slow vital capacity (SVC)

Time frame: SVC

Treatment tolerance

Treatment tolerance based on dose reductions and dose terminations due to adverse events

Time frame: 24 weeks

Data from ClinicalTrials.gov

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