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

• Sponsor: Collaborative Medicinal Development Pty Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04313166
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Drug: Cu(II)ATSM	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
• Actual Study Start Date: Mar 19, 2020
• Actual Primary Completion Date: Nov 18, 2021
• Actual Study Completion Date: Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cu(II)ATSM copper-containing synthetic small molecule	Drug: Cu(II)ATSM; cooper-containing synthetic small molecule; Other Names: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)

Outcome Measures

Primary Outcome Measures

1. 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

1. Treatment-related changes in cognitive function [24 weeks]

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

2. Treatment-related changed in respiratory function [SVC]

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

3. Treatment tolerance [24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Macquarie University	Macquarie Park	New South Wales	Australia

Sponsors and Collaborators

• Collaborative Medicinal Development Pty Limited

Investigators

• Principal Investigator: Dominic Rowe, MD, Macquarie University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Collaborative Medicinal Development Pty Limited
• ClinicalTrials.gov Identifier: NCT04313166
• Other Study ID Numbers: CMD-2020-001
• First Posted: Mar 18, 2020
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Copper

Study Results

No Results Posted as of Feb 17, 2022