A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

Last updated: December 7, 2023
Sponsor: Clene Nanomedicine
Overall Status: Completed

Phase

2/3

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

CNM-Au8

Clinical Study ID

NCT04626921
CNMAu8.201LTE
  • Ages 18-55
  • All Genders

Study Summary

Open-label, long-term extension study available to participants who have completed CNMAu8.201.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have completed study CNMAu8.201.
  • Able to understand and give written informed consent.

Exclusion

Exclusion Criteria:

  • Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS)study.
  • Positive pregnancy test.
  • Any history of previous malignancy, with the exception of basal cell carcinoma of theskin or in situ carcinoma of the cervix, post documented full resections, with cleanmargins.
  • Based on the Investigator's judgment, any concurrent chronic or acute illness orunstable medical condition that could confound the results of safety assessments,increase risk to the participant, or lead to difficulty complying with the protocol;any untreated or unstable psychiatric disease including depression, bipolar andpsychosis.
  • Participant is considered a suicide risk in the opinion of the Investigator, haspreviously made a suicide attempt, or is currently demonstrating active suicidalideation. Following clinical and serology sample analysis conducted at the end-of-study visit forCNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension studyif any of the following criteria are met, at the discretion of the Medical Monitor and/orSponsor's Medical Representative:
  • Positive serology for viral hepatitis B and/or C and/or human immunodeficiency virus (HIV).
  • Abnormal liver function tests (aspartate aminotransferase [ASAT] or alanineaminotransferase [ALAT] > 2x upper limit of normal range (ULN) or total bilirubin > 2xULN or alkaline phosphatase (AP) > 3x ULN).
  • Participants with clinically significant hepatic or renal dysfunction or clinicallaboratory findings that would limit the interpretability of change in liver or kidneyfunction (e.g., glomerular filtration rate < 40 mL/min [based on creatinine clearanceaccording to Cockcroft-Gault equation]), or those with low platelet counts (<150 x 109per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils permicroliter) at the EOS visit for CNMAu8.201 (Visionary-MS).

Study Design

Total Participants: 55
Treatment Group(s): 1
Primary Treatment: CNM-Au8
Phase: 2/3
Study Start date:
October 22, 2020
Estimated Completion Date:
September 06, 2023

Study Description

This open-label, long-term extension study is only available to participants who have completed CNMAu8.201 (VISIONARY-MS). The Week 48/End-of-Study Visit for study CNMAu8.201 (VISIONARY-MS) will serve to establish the Baseline for electrophysiological, functional, morphological vision testing, as well as the neurological and outcome assessments. Participants will receive open-label CNM-Au8 throughout the study. All participants will receive a daily dose of 30 mg CNM-Au8 for the entire open-label, long-term extension study. The dose for participants may be adjusted once efficacy and safety data from study CNMAu8.201 becomes available, which may occur after participants have already started this study. Based upon a review of data and Sponsor or PI recommendation, this open-label, long-term extension study may be discontinued once each participant reaches her/his 48-week visit.

Connect with a study center

  • Sydney Brain Mind Centre

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Leonards Hill, New South Wales 2065
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Menzies Institute for Medical Research

    Hobart, TAZ 7000
    Australia

    Site Not Available

  • Lyell McEwin Hospital

    Elizabeth, Vale 5112
    Australia

    Site Not Available

  • Austin Health Department of Neurology

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Centre Department of Neuroscience

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • The Perron Institute

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • University of British Columbia

    Vancouver, British Columbia V6T 1Z3
    Canada

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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