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

A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04313166

Enrollment

Registered

2020-03-18

Start date

2020-03-19

Completion date

2022-02-15

Last updated

2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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

Detailed description

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

Interventions

DRUGCu(II)ATSM

cooper-containing synthetic small molecule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment-related changes in disease severity	24 weeks	Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)

Secondary

Measure	Time frame	Description
Treatment-related changes in cognitive function	24 weeks	Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
Treatment-related changed in respiratory function	SVC	Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
Treatment tolerance	24 weeks	Treatment tolerance based on dose reductions and dose terminations due to adverse events

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026