CompletedPhase 2Phase 3Relapsing MSNCT04626921

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • CNM-Au8

What it measured

Main measures

  • Change in Best-Corrected Low-Contrast Letter Acuity score.

    2 years

    Vision
  • Incidence of treatment-emergent AEs throughout the study.

    2 years

    Safety

Other measures (1)

  • Measure of neurological function assessed by a functional composite responder analysis.

    2 years

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Participants must have completed study CNMAu8.201. * Able to understand and give written informed consent. 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 the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins. * Based on the Investigator's judgment, any concurrent chronic or acute illness or unstable 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 and psychosis. * Participant is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Following clinical and serology sample analysis conducted at the end-of-study visit for CNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension study if any of the following criteria are met, at the discretion of the Medical Monitor and/or Sponsor'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 alanine aminotransferase [ALAT] > 2x upper limit of normal range (ULN) or total bilirubin > 2x ULN or alkaline phosphatase (AP) > 3x ULN). * Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function (e.g., glomerular filtration rate \< 40 mL/min [based on creatinine clearance according to Cockcroft-Gault equation]), or those with low platelet counts (\<150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils per microliter) at the EOS visit for CNMAu8.201 (Visionary-MS).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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    Related trials

    History

      1. Started

        Oct 2020

      2. Main results due

        May 2023

      3. Finished

        Sept 2023

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