Table 4.
Phase III and IV clinical trials of remyelination treatments including patients older than 55 years.
| Agent (ref) | Design/patients | Primary outcome result/status |
|---|---|---|
| Adrenocorticotropic Hormone (NCT02446886) | Phase IV, randomized, open-label trial. RRMS or SPMS; ≥18 years old. |
Completed. No publications available |
| MD1003 (high-dose biotin) (204) | Randomized, double-blind, parallel-group, placebo-controlled trial. PPMS or SPMS; 18-65 years old. |
39 (12%) of MD1003-treated patients achieved disability reversal at month 12, confirmed at month 15, vs 29 (9%) of the placebo-treated patients (not significant). |
| MD1003 (high-dose biotin) (MS-ON) (205) | 6-month, randomized, double-blind, placebo-controlled study. MS; 18-75 years old. |
The mean change in VA was not larger with MD1003 than with placebo (p = 0.66). |
ref, reference; RRMS, relapsing-remitting multiple sclerosis; RSPMS, relapsing secondary progressive multiple sclerosis; SPMS, secondary progressive multiple sclerosis; VA, visual acuity.