Back to resultsA Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis (VISIONMS-LTE)
Primary Purpose
Relapsing Multiple Sclerosis
Status
Active
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
CNM-Au8
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring MS, RMS, Multiple Sclerosis, Demyelination, Remyelination, Optic Neuropathy, Optic Neuritis, Gold, Nanocrystal, Multifocal VEP, Full Field VEP, Low contrast letter acuity
Eligibility Criteria
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).
Sites / Locations
- Sydney Brain Mind Centre
- John Hunter Hospital
- Princess Alexandra Hospital
- Menzies Institute for Medical Research
- The Alfred Centre Department of Neuroscience
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active treatment with 30 mg of CNM-Au8
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Best-Corrected Low-Contrast Letter Acuity score.
Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.
Incidence of treatment-emergent AEs throughout the study.
Safety endpoint include incidence of treatment-emergent AEs.
Secondary Outcome Measures
Measure of neurological function assessed by a functional composite responder analysis.
Mean change in Functional Composite Responder Analysis Score from Baseline to End of Study.
Full Information
NCT ID
NCT04626921
First Posted
October 30, 2020
Last Updated
March 30, 2023
Sponsor
Clene Nanomedicine
Collaborators
George Clinical
1. Study Identification
Unique Protocol Identification Number
NCT04626921
Brief Title
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Acronym
VISIONMS-LTE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clene Nanomedicine
Collaborators
George Clinical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open-label, long-term extension study available to participants who have completed CNMAu8.201.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
MS, RMS, Multiple Sclerosis, Demyelination, Remyelination, Optic Neuropathy, Optic Neuritis, Gold, Nanocrystal, Multifocal VEP, Full Field VEP, Low contrast letter acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-Label, Long-Term Extension.
Masking
None (Open Label)
Masking Description
None, open-label.
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment with 30 mg of CNM-Au8
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CNM-Au8
Intervention Description
30 mg of CNM-Au8
Primary Outcome Measure Information:
Title
Change in Best-Corrected Low-Contrast Letter Acuity score.
Description
Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.
Time Frame
2 years
Title
Incidence of treatment-emergent AEs throughout the study.
Description
Safety endpoint include incidence of treatment-emergent AEs.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Measure of neurological function assessed by a functional composite responder analysis.
Description
Mean change in Functional Composite Responder Analysis Score from Baseline to End of Study.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Change in best corrected Low-Contrast Letter Acuity score for total number of correct letter.
Description
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.
Time Frame
2 years
Title
Change in Best Corrected High Contrast Visual Acuity
Description
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.
Time Frame
2 years
Title
VEP latency for Multi-Focal visual evoked potential.
Description
Mean change in average mf-VEP latency for the affected eye from the average Baseline mf-VEP latency of the affected eye.
Time Frame
2 years
Title
VEP latency for Full Field Visual Evoked Potential
Description
Mean change in average ff-VEP latency for the affected eye from the average Baseline ff-VEP latency of the affected eye.
Time Frame
2 years
Title
VEP Amplitude for Multi-Focal Visual Evoked Potential
Description
Mean change in average amplitude for the affected eye from the average Baseline of the affected eye (for all measurable segments).
Time Frame
2 years
Title
VEP Amplitude for Full Field Visual Evoked Potential
Description
Mean change in average amplitude for the affected eye from the average Baseline of the affected eye (for all measurable segments).
Time Frame
2 years
Title
OCT of the Retinal Nerve Fiber Layer (RNFL) by Peripapillary Scan
Description
Percentage change in average thicknesses of the RNFL for the affected eye and the fellow eye from their respective Baselines.
Time Frame
2 years
Title
OCT of the Retinal Layers by Macular Scan evaluating Ganglion cell and inner plexiform.
Description
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.
Time Frame
2 years
Title
OCT of the Retinal Layers by Macular Scan evaluating Ganglion cell layer.
Description
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.
Time Frame
2 years
Title
OCT of the Retinal Layers by Macular Scan evaluating Inner nuclear layer.
Description
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.
Time Frame
2 years
Title
OCT of the Retinal Layers by Macular Scan evaluating outer nuclear layer.
Description
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.
Time Frame
2 years
Title
MRI Evaluation of the Mean change in whole brain and OR T2 lesion volume.
Description
Mean change in whole brain and OR T2 lesion volume from Baseline
Time Frame
2 years
Title
MRI Evaluation of the Mean change in whole brain and optic radiation T1 hypo-intense lesion volume.
Description
Mean change in whole brain and optic radiation T1 hypointense lesion volume from Baseline.
Time Frame
2 years
Title
MRI Evaluation of the Proportion of Baseline Gd+ lesions converting to black holes.
Description
Proportion of Baseline Gd+ lesions converting to black holes.
Time Frame
2 years
Title
MRI Evaluation of the Volume of Baseline Gd+ lesions converting to T1 hypointense lesions.
Description
Volume of Baseline Gd+ lesions converting to T1 hypointense lesions.
Time Frame
2 years
Title
MRI Evaluation of the Mean percent whole brain volume change (PBVC) from baseline.
Description
Mean percent whole brain volume change (PBVC) from baseline.
Time Frame
2 years
Title
MRI Evaluation of the Mean Percent Cerebral Cortical Change from Baseline
Description
Mean Percent Cerebral Cortical Change from Baseline
Time Frame
2 years
Title
MRI Evaluation of the Mean Percent Thalamic Volume Change from Baseline.
Description
Mean Percent Thalamic Volume Change from Baseline.
Time Frame
2 years
Title
MRI Evaluation of the Mean Percent Deep Grey Nuclei Volume Change from Baseline.
Description
Mean Percent Deep Grey Nuclei Volume Change from Baseline
Time Frame
2 years
Title
MRI Evaluation of the Mean change in number of whole brain new/enlarging T2 lesion(s) from baseline.
Description
Mean change in number of whole brain new/enlarging T2 lesion(s) from baseline.
Time Frame
2 years
Title
Mean change in whole brain DTI/MTR from baseline.
Description
DTI- Diffusion Tensor Imaging, MTR- Magnetization Transfer Ratio.
Time Frame
2 years
Title
Mean change in optic radiation lesional/non-lesional fibre DTI / MTR difference from Baseline (fiber based, individually reported for each baseline OR lesion).
Description
Individual OR lesion MRI analysis
Time Frame
2 years
Title
Mean change in MWF from Baseline in the whole brain.
Description
Myelin Water Fraction MRI Analysis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Sydney Brain Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Menzies Institute for Medical Research
City
Hobart
State/Province
TAZ
ZIP/Postal Code
7000
Country
Australia
Facility Name
The Alfred Centre Department of Neuroscience
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
We'll reach out to this number within 24 hrs