Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study
| Autor: | Kunio Tashiro, Yasuo Ohashi, Koichi Okamoto, Shigeki Kuzuhara, Takao Takase, Yasuo Iwasaki, Takahisa Hanada, Hiroki Shimizu, Masanori Nakagawa, Takashi Imai, Ryuji Kaji |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Placebo Injections Intramuscular law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine Clinical endpoint medicine Humans Amyotrophic lateral sclerosis Survival rate Aged Motor Neurons business.industry Amyotrophic Lateral Sclerosis Middle Aged medicine.disease Respiration Artificial Clinical trial Survival Rate Psychiatry and Mental health Vitamin B 12 Neuromuscular 030220 oncology & carcinogenesis Methylcobalamin Cohort Surgery Female Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Journal of Neurology, Neurosurgery, and Psychiatry |
| ISSN: | 1468-330X |
| Popis: | ObjectiveTo evaluate the efficacy and safety of intramuscular ultra-high-dose methylcobalamin in patients with amyotrophic lateral sclerosis (ALS).Methods373 patients with ALS (El Escorial definite or probable; laboratory-supported probable; duration ≤36 months) were randomly assigned to placebo, 25 mg or 50 mg of methylcobalamin groups. The primary endpoints were the time interval to primary events (death or full ventilation support) and changes in the Revised ALS Functional Rating Scale (ALSFRS-R) score from baseline to week 182. Efficacy was also evaluated using post-hoc analyses in patients diagnosed early (entered ≤12 months after symptom onset).ResultsNo significant differences were detected in either primary endpoint (minimal p value=0.087). However, post-hoc analyses of methylcobalamin-treated patients diagnosed and entered early (≤12 months’ duration) showed longer time intervals to the primary event (pConclusionAlthough ultra-high-dose methylcobalamin did not show significant efficacy in the whole cohort, this treatment may prolong survival and retard symptomatic progression without major side effects if started early.Trial registration numberNCT00444613. |
| Databáze: | OpenAIRE |
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