Abstract
The topiramate study was a 12-month randomized placebo-controlled trial in patients with ALS. Follow-up evaluation of the placebo group (n = 97) constituted a well-described cohort of patients with ALS, in whom multiple outcome measures were assessed at 3-month intervals. During the 12-month study period, the decline of forced vital capacity (FVC%) and ALS functional rating scale (ALSFRS) was linear, whereas the decline of maximum voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z scores was curvilinear. Rates of FVC% and ALFRS decline, but not of MVIC-arm or MVIC-grip, were independent predictors of survival.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Amyotrophic Lateral Sclerosis / drug therapy*
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Amyotrophic Lateral Sclerosis / mortality
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Amyotrophic Lateral Sclerosis / physiopathology
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Arm / physiopathology*
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Biomarkers
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Female
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Fructose / analogs & derivatives*
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Fructose / therapeutic use
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Hand Strength*
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Humans
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Isometric Contraction
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Life Tables
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Male
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Middle Aged
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Outcome Assessment, Health Care / methods*
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Predictive Value of Tests
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Proportional Hazards Models
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Randomized Controlled Trials as Topic / methods
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Severity of Illness Index*
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Survival Analysis
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Topiramate
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Treatment Outcome
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Vital Capacity*
Substances
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Biomarkers
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Topiramate
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Fructose