CuATSM Compared With Placebo for Treatment of ALS/MND

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

ANCOVA will be used to compare efficacy endpoints between CuATSM and placebo groups

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

placebo controlled

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cu(II)ATSM

Intervention Type DRUG

oral suspension

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.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

oral suspension

Interventions

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Cu(II)ATSM

oral suspension

Intervention Type DRUG

Placebos

oral suspension

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No