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

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Cu(II)ATSM

• Registration Number: NCT04313166
• Lead Sponsor: Collaborative Medicinal Development Pty Limited

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

Study Timeline

• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-18
• Study Start: 2020-03-19
• Primary Completion: 2021-11-18
• Status Verified: 2022-02
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cu(II)ATSM	Cu(II)ATSM	copper-containing synthetic small molecule

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Macquarie University; 🇦🇺 Macquarie Park, New South Wales, Australia