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. 2024 Apr 5;15:1379538. doi: 10.3389/fimmu.2024.1379538

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.