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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04082832
Other study ID # CMD-2019-001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 30, 2019
Est. completion date December 30, 2020

Study information

Verified date November 2019
Source Collaborative Medicinal Development Pty Limited
Contact Kay Noel, PhD
Phone (415) 444 9600
Email Kay.Noel@colMedDev.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Cu(II)ATSM
oral suspension
Placebos
oral suspension

Locations

Country Name City State
Australia Macquarie University Macquarie 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 Revised ALS Functional Rating Scale (ALSFRS-R) total score (range: 48 [best] to 0 [worst]) assessment of disease severity 24 weeks
Primary Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS) total score (range: 136 [best] to 0 [worst]) assessment of cognitive function 24 weeks
Secondary seated slow vital capacity (SVC) assessment of respiratory function 24 weeks
Secondary rate of adverse events tolerability assessment 24 weeks
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