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| Name | Class |
|---|---|
| George Clinical | UNKNOWN |
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Open-label, long-term extension study available to participants who have completed CNMAu8.201.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment with 30 mg of CNM-Au8 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNM-Au8 | Drug | 30 mg of CNM-Au8 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Incidence of treatment-emergent AEs throughout the study. | Safety endpoint include incidence of treatment-emergent AEs. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected Low-Contrast Letter Acuity score for total number of correct letter. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Brain Mind Centre | Camperdown | New South Wales | 2050 | Australia | ||
| John Hunter Hospital |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003711 | Demyelinating Diseases |
| D009901 | Optic Nerve Diseases |
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
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Open-Label, Long-Term Extension.
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None, open-label.
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| Change in Best Corrected High Contrast Visual Acuity | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Mean percent whole brain volume change (PBVC) from baseline. | 2 years |
| MRI Evaluation of the Mean Percent Cerebral Cortical Change from Baseline | Mean Percent Cerebral Cortical Change from Baseline | 2 years |
| MRI Evaluation of the Mean Percent Thalamic Volume Change from Baseline. | Mean Percent Thalamic Volume Change from Baseline. | 2 years |
| MRI Evaluation of the Mean Percent Deep Grey Nuclei Volume Change from Baseline. | 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. | 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. | 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). | Individual OR lesion MRI analysis | 2 years |
| Mean change in MWF from Baseline in the whole brain. | Myelin Water Fraction MRI Analysis | 2 years |
| New Lambton Heights |
| New South Wales |
| 2305 |
| Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Menzies Institute for Medical Research | Hobart | TAZ | 7000 | Australia |
| The Alfred Centre Department of Neuroscience | Melbourne | Victoria | 3004 | Australia |
| D007154 | Immune System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |