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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
30 mg of CNM-Au8
Sydney Brain Mind Centre
Camperdown, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Menzies Institute for Medical Research
Hobart, TAZ, Australia
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.
Time frame: 2 years
Incidence of treatment-emergent AEs throughout the study.
Safety endpoint include incidence of treatment-emergent AEs.
Time frame: 2 years
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.
Time frame: 2 years
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The Alfred Centre Department of Neuroscience
Melbourne, Victoria, Australia