A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Completed Study CMD-2016-001

Study Purpose:

Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase I ,Phase II

Study Chair(s)/Principal Investigator(s):

Dominic Rowe, MD Macquarie University

Clinicaltrials.gov ID (11 digit #):

NCT03136809

Neals Affiliated?

No

Coordinating Center Contact Information


Kay Noel, PhD / .(JavaScript must be enabled to view this email address) / 415-444-9602
Craig Rosenfeld, MD / .(JavaScript must be enabled to view this email address) / 415-444-9602

Full Study Summary:

Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment. The same safety assessments as in the CMD-2016-001 study will be conducted after each cycle of treatment and the same efficacy assessments as in the CMD-2016-001 study will be conducted after every 3 cycles of treatment. Treatment will continue until the first to occur of (1) Investigator considers the patient is no longer deriving benefit from CuATSM treatment, (2) patient develops dependence on mechanical ventilation where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use, or (3) the patient withdraws consent.

Study Sponsor:

Collaborative Medicinal Development Pty Limited

Participant Duration:

24 months

Estimated Enrollment:

50

Estimated Study Start Date:

05/08/2017

Estimated Study Completion Date:

05/31/2019

Posting Last Modified Date:

05/17/2017

Date Study Added to alsconsortium.org:

05/17/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Signed informed consent prior to initiation of any study-specific procedures and treatment
    Documented completion of protocol-specific assessments following completion of six 28-day treatment cycles in study CMD-2016-001
    Principal Investigator considers the patient would benefit from continued treatment with Cu(II)ATSM
    Not taking riluzole or on the same (or lower) dose used during the CMD-2016-001 study
    Adequate bone marrow reserve, renal and liver function
    Women and men with partners of childbearing potential must take effective contraception while on study treatment

    Exclusion Criteria:

    Inability to swallow oral medications or presence of a gastrointestinal disorder (e.g.,malabsorption) deemed to jeopardize intestinal absorption of study drug
    Dependence on mechanical ventilation (invasive or non-invasive) for any part of day or night, where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use
    Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
    Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6

  • Site Contact Information

    Macquarie University
    Dominic Rowe, MD / .(JavaScript must be enabled to view this email address) / Sydney, Australia 2109
    Australia