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Eye-Tracking Control to Assess Cognitive Functions in Patients with Amyotrophic Lateral Sclerosis
Published on: October 13, 2016
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Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled
Ryuji Kaji1, Takashi Imai2,3, Yasuo Iwasaki4
1Department of Neurology, Tokushima University Hospital, Tokushima, Japan rkaji@tokushima-u.ac.jp.
Journal of Neurology, Neurosurgery, and Psychiatry
|January 15, 2019
Summary
Ultra-high-dose methylcobalamin did not significantly improve outcomes for all amyotrophic lateral sclerosis (ALS) patients. However, early treatment may extend survival and slow disease progression in ALS.
Area of Science:
- Neurology
- Clinical Trials
- Neurodegenerative Diseases
Background:
- Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with limited treatment options.
- Methylcobalamin, a form of vitamin B12, has been investigated for potential therapeutic effects in neurological disorders.
Purpose of the Study:
- To assess the efficacy and safety of high-dose intramuscular methylcobalamin in patients diagnosed with amyotrophic lateral sclerosis (ALS).
Main Methods:
- A randomized, placebo-controlled trial involving 373 ALS patients.
- Participants received placebo, 25 mg, or 50 mg of methylcobalamin.
- Primary endpoints included time to primary events (death or ventilation) and changes in ALSFRS-R score over 182 weeks.
Main Results:
- No statistically significant differences in primary endpoints were observed across the entire patient cohort.
- Subgroup analyses revealed that early-diagnosed patients (within 12 months) treated with methylcobalamin had a longer time to primary events and slower ALSFRS-R decline.
- Treatment-related adverse events were infrequent and comparable across all groups.
Conclusions:
- Ultra-high-dose methylcobalamin did not demonstrate significant efficacy in the overall ALS population.
- Early initiation of methylcobalamin treatment may offer benefits in prolonging survival and slowing symptomatic progression in ALS patients without significant side effects.
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