Functional outcome measures as clinical trial endpoints in ALS.
rct · Level II
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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.
Medical subject headings
- Amyotrophic Lateral Sclerosis
- Arm
- Fructose
- Hand Strength
- Outcome Assessment, Health Care
- Severity of Illness Index
- Vital Capacity
Anatomy
- hand