- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082832
CuATSM Compared With Placebo for Treatment of ALS/MND
November 4, 2019 updated by: Collaborative Medicinal Development Pty Limited
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Cu(II)ATSM in Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease
Multicenter, randomized, double-blind, placebo controlled study to assess the tolerabilty and efficacy of CuATSM in patients with ALS/MND.
Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment.
Study drug is administered orally, once a day in fasted state (before breakfast).
Assessments for safety (physical examination, vital signs, hematology, serum chemistry adverse events) will be conducted at baseline and following each cycle of treatment.
Assessments for efficacy (Revised ALS Functional Rating Scale [ASLFRS-R] score, and Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen [ECAS] score, and seated slow vital capacity [SVC]) will be conducted at baseline and following 2, 4 and 6 cycles of treatment.
Analysis of covariance (ANCOVA) will be used to compare efficacy endpoints between CuATSM and placebo groups.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kay Noel, PhD
- Phone Number: (415) 444 9600
- Email: Kay.Noel@colMedDev.com
Study Contact Backup
- Name: Craig Rosenfeld, MD
- Phone Number: (415) 444 9600
- Email: CraigR@ColMedDev.com
Study Locations
-
-
New South Wales
-
Macquarie, New South Wales, Australia
- Recruiting
- Macquarie University
-
Contact:
- Dominic Rowe, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- signed informed consent
- familial or sporadic ALS/MNS by Awaji-shima Consensus Recommendations
- not taking riluzole or on stable dose of riluzole for 4 weeks prior to screening visit
- no prior exposure to agents other than riluzole for treatment of ALS
- adequate bone marrow reserve, renal and liver function
- women of childbearing potential must have a negative pregnancy test and be non-lactating
- women and men with partners of childbearing potential must take effective contraception while on treatment
Exclusion Criteria:
- presence of a gastrointestinal disorder (eg, malabsorption) that might jeopardize intestinal absorption of study drug
- inability to perform seated SVC
- known immune compromising illness or treatment
- drug abuse or alcoholism
- clinically significant or active cardiovascular disease
- acute or chronic infection
- diagnosis of malignancy within 2 years prior to screening
- dementia that may affect patient understanding and/or compliance with study requirements and procedures
- current use of strong inducers or inhibitors of CYPs 2C19 and 2D6
- current us of medications (other than riluzole) that are metabolized predominantly by CYP 1A2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cu(II)ATSM
Cu(II)ATSM Powder for Oral Suspension, 36 mg, to be reconstituted with Diluent (15 mL of sugar-free flavored pharmaceutical syrup) to provide an oral suspension for immediate consumption.
Specified dose is 72 mg (2 bottles) taken fasting, before breakfast each day.
|
oral suspension
|
Placebo Comparator: Placebo Powder for Oral Suspension
Placebo Powder for Oral Suspension, to be reconstituted with Diluent (15 mL of sugar-free flavored pharmaceutical syrup) to provide an oral suspension for immediate consumption.
Specified dose is 72 mg (2 bottles) taken fasting, before breakfast each day.
|
oral suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised ALS Functional Rating Scale (ALSFRS-R) total score (range: 48 [best] to 0 [worst])
Time Frame: 24 weeks
|
assessment of disease severity
|
24 weeks
|
Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS) total score (range: 136 [best] to 0 [worst])
Time Frame: 24 weeks
|
assessment of cognitive function
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
seated slow vital capacity (SVC)
Time Frame: 24 weeks
|
assessment of respiratory function
|
24 weeks
|
rate of adverse events
Time Frame: 24 weeks
|
tolerability assessment
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
September 2, 2019
First Submitted That Met QC Criteria
September 6, 2019
First Posted (Actual)
September 9, 2019
Study Record Updates
Last Update Posted (Actual)
November 6, 2019
Last Update Submitted That Met QC Criteria
November 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMD-2019-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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