By MIREI JINGUJI/ Staff Writer
May 10, 2022 at 15:54 JST
Tokushima University (Asahi Shimbun file photo)
TOKUSHIMA--A drug normally used to alleviate nerve pain and backaches can slow the progression of the early stages of amyotrophic lateral sclerosis (ALS), researchers from Tokushima University have found.
The university released the results of a clinical trial on May 10 that confirmed the effectiveness of methylcobalamin in treating the intractable disease.
“The drug can also help prolong the patient’s life,” said Ryuji Kaji, a specially appointed professor at Tokushima University and a member of the research team.
“We’re aiming to seek regulatory approval as soon as possible.”
Eisai Co., which manufactures and sells methylcobalamin, said it plans to apply for approval for use as a drug to treat ALS by the end of March 2024.
The clinical trial was conducted at 25 medical institutions nationwide involving ALS patients who developed symptoms within a year.
The participants were divided into two groups. One group received 100 times the amount of methylcobalamin used for nerve pain and other ailments, while the other group was given a placebo.
Both groups were administered their respective drugs twice a week by intramuscular injection for 16 weeks to compare the progress of their symptoms.
The results showed 63 patients who received methylcobalamin were about 43 percent less likely to see their symptoms progress at the 16th week of treatment compared to the other 63 who were given a placebo.
The research team also found patients who were administered methylcobalamin along with riluzole, an existing drug for treating ALS, were 45 percent less likely to experience the progression of their symptoms compared to those who received only riluzole.
Participants who were administered methylcobalamin did not develop serious side effects, according to the team.
A subgroup analysis of past clinical trials by Tokushima University showed the administration of the same amount of methylcobalamin used in the latest study can delay death or the use of ventilators by about 600 days in patients who developed symptoms within a year.
ALS is an incurable disease in which nerve damage causes patients to progressively lose control of their muscles. They gradually become completely paralyzed.
There is no drug currently available that can both slow the progression of the disease and prolong the patient’s life, according to the researchers.
The team’s findings were published on May 10 in the U.S. science journal JAMA Neurology: (https://doi.org/10.1001/jamaneurol.2022.0901).
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