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NCT04313166 Clinical Trial

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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04313166
Other study ID # CMD-2020-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 19, 2020
Est. completion date February 15, 2022

Study information
Verified date February 2022
Source Collaborative Medicinal Development Pty Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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]

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date February 15, 2022
Est. primary completion date November 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Cu(II)ATSM
cooper-containing synthetic small molecule

Locations
Country Name City State
Australia Macquarie University Macquarie Park New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Collaborative Medicinal Development Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment-related changes in disease severity Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R) 24 weeks
Secondary Treatment-related changes in cognitive function Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score 24 weeks
Secondary Treatment-related changed in respiratory function Treatment-related changes in respiratory function by seated slow vital capacity (SVC) SVC
Secondary Treatment tolerance Treatment tolerance based on dose reductions and dose terminations due to adverse events 24 weeks
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