- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626921
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis (VISIONMS-LTE)
December 7, 2023 updated by: Clene Nanomedicine
VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Open-label, long-term extension study available to participants who have completed CNMAu8.201.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Sydney Brain Mind Centre
-
New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital
-
-
Queensland
-
Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
-
-
TAZ
-
Hobart, TAZ, Australia, 7000
- Menzies Institute for Medical Research
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- The Alfred Centre Department of Neuroscience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active treatment with 30 mg of CNM-Au8
Highly pure elemental Au nanocrystals are suspended in deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) concentrated up to 0.5 mg/mL (500 ppm) Au.
|
30 mg of CNM-Au8
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Best-Corrected Low-Contrast Letter Acuity score.
Time Frame: 2 years
|
Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.
|
2 years
|
Incidence of treatment-emergent AEs throughout the study.
Time Frame: 2 years
|
Safety endpoint include incidence of treatment-emergent AEs.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of neurological function assessed by a functional composite responder analysis.
Time Frame: 2 years
|
Mean change in Functional Composite Responder Analysis Score from Baseline to End of Study.
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in best corrected Low-Contrast Letter Acuity score for total number of correct letter.
Time Frame: 2 years
|
BC-LCLA score is the sum of all correctly identified letters up to the last line on the 2.5% Sloan Chart able in which three (3) or more letters are correctly read plus all correct letters on the following line.
Scale is 70 - 0 with 70 being able to see all letters, 0 was unable to read any letters.
|
2 years
|
Change in Best Corrected High Contrast Visual Acuity
Time Frame: 2 years
|
Mean change from Baseline in best-corrected high contrast visual acuity (BCHCVA), as measured by EDTRS in the affected and fellow eye.
Scale is 70 - 0 with 70 being able to see all letters, 0 was unable to read any letters.
|
2 years
|
VEP latency for Multi-Focal visual evoked potential.
Time Frame: 2 years
|
Mean change in average mf-VEP latency for the affected eye from the average Baseline mf-VEP latency of the affected eye.
|
2 years
|
VEP latency for Full Field Visual Evoked Potential
Time Frame: 2 years
|
Mean change in average ff-VEP latency for the affected eye from the average Baseline ff-VEP latency of the affected eye.
|
2 years
|
VEP Amplitude for Multi-Focal Visual Evoked Potential
Time Frame: 2 years
|
Mean change in average amplitude for the affected eye from the average Baseline of the affected eye (for all measurable segments).
|
2 years
|
VEP Amplitude for Full Field Visual Evoked Potential
Time Frame: 2 years
|
Mean change in average amplitude for the affected eye from the average Baseline of the affected eye (for all measurable segments).
|
2 years
|
OCT of the Retinal Nerve Fiber Layer (RNFL) by Peripapillary Scan
Time Frame: 2 years
|
Percentage change in average thicknesses of the RNFL for the affected eye and the fellow eye from their respective Baselines.
|
2 years
|
OCT of the Retinal Layers by Macular Scan evaluating Ganglion cell and inner plexiform.
Time Frame: 2 years
|
Percentage change in mean thicknesses of the GCIP for the affected eye and the fellow eye from their respective Baselines as determined by segmentation of SD-OCT.
|
2 years
|
OCT of the Retinal Layers by Macular Scan evaluating Ganglion cell layer.
Time Frame: 2 years
|
Percentage change in mean thicknesses of the GCL for the affected eye and the fellow eye from their respective Baselines as determined by segmentation of SD-OCT.
|
2 years
|
OCT of the Retinal Layers by Macular Scan evaluating Inner nuclear layer.
Time Frame: 2 years
|
Percentage change in mean thicknesses of the inner nuclear layer for the affected eye and the fellow eye from their respective Baselines as determined by segmentation of SD-OCT.
|
2 years
|
OCT of the Retinal Layers by Macular Scan evaluating outer nuclear layer.
Time Frame: 2 years
|
Percentage change in mean thicknesses of the outer nuclear layer for the affected eye and the fellow eye from their respective Baselines as determined by segmentation of SD-OCT.
|
2 years
|
MRI Evaluation of the Mean change in whole brain and OR T2 lesion volume.
Time Frame: 2 years
|
Mean change in whole brain and OR T2 lesion volume from Baseline
|
2 years
|
MRI Evaluation of the Mean change in whole brain and optic radiation T1 hypo-intense lesion volume.
Time Frame: 2 years
|
Mean change in whole brain and optic radiation T1 hypointense lesion volume from Baseline.
|
2 years
|
MRI Evaluation of the Proportion of Baseline Gd+ lesions converting to black holes.
Time Frame: 2 years
|
Proportion of Baseline Gd+ lesions converting to black holes.
|
2 years
|
MRI Evaluation of the Volume of Baseline Gd+ lesions converting to T1 hypointense lesions.
Time Frame: 2 years
|
Volume of Baseline Gd+ lesions converting to T1 hypointense lesions.
|
2 years
|
MRI Evaluation of the Mean percent whole brain volume change (PBVC) from baseline.
Time Frame: 2 years
|
Mean percent whole brain volume change (PBVC) from baseline.
|
2 years
|
MRI Evaluation of the Mean Percent Cerebral Cortical Change from Baseline
Time Frame: 2 years
|
Mean Percent Cerebral Cortical Change from Baseline
|
2 years
|
MRI Evaluation of the Mean Percent Thalamic Volume Change from Baseline.
Time Frame: 2 years
|
Mean Percent Thalamic Volume Change from Baseline.
|
2 years
|
MRI Evaluation of the Mean Percent Deep Grey Nuclei Volume Change from Baseline.
Time Frame: 2 years
|
Mean Percent Deep Grey Nuclei Volume Change from Baseline
|
2 years
|
MRI Evaluation of the Mean change in number of whole brain new/enlarging T2 lesion(s) from baseline.
Time Frame: 2 years
|
Mean change in number of whole brain new/enlarging T2 lesion(s) from baseline.
|
2 years
|
Mean change in whole brain DTI/MTR from baseline.
Time Frame: 2 years
|
DTI- Diffusion Tensor Imaging, MTR- Magnetization Transfer Ratio.
|
2 years
|
Mean change in optic radiation lesional/non-lesional fibre DTI / MTR difference from Baseline (fiber based, individually reported for each baseline OR lesion).
Time Frame: 2 years
|
Individual OR lesion MRI analysis
|
2 years
|
Mean change in MWF from Baseline in the whole brain.
Time Frame: 2 years
|
Myelin Water Fraction MRI Analysis
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2020
Primary Completion (Actual)
May 29, 2023
Study Completion (Actual)
September 6, 2023
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
November 6, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNMAu8.201LTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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