, efficacy was higher for participants who were also taking riluzole, which is approved by the US Food and Drug Administration to treat ALS. The study included ambulatory patients at 25 neurology centers in Japan who were diagnosed with definite or probable ALS and whose symptoms began within the previous year.
These patients were randomly assigned to receive 50 mg of methylcobalamin or placebo. The primary endpoint was change in ALSFRS-R total score. At 16 weeks, this total score was -2.66 in the methylcobalamin group and -4.63 in the placebo group . In the 90% of patients also taking riluzole, the difference in favor of methylcobalamin was even greater . The difference in ALSFRS-R total score between the active drug and placebo amounted to 43% in all patients and 45% in those using riluzole.
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