Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04626921 | A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | PHASE2 | COMPLETED | 55 | — | — | Oct 22, 2020 | Sep 6, 2023 | Dec 8, 2023 | 5 | Australia |
Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.
Safety endpoint include incidence of treatment-emergent AEs.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| CNM-Au8 | DRUG | 30 mg of CNM-Au8 |
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 mal...