Abstract
OBJECTIVE: In this study, we used data from clinical trials of dalfampridine (fampridine outside the United States) to re-examine the clinical meaningfulness of Timed 25-Foot Walk (T25FW) changes. METHODS: Pooled data were analyzed from 2 phase III randomized placebo-controlled clinical trials of dalfampridine in multiple sclerosis (MS) (n = 533). Walking speed (T25FW) and patient-reported walking ability (MS Walking Scale-12 [MSWS-12]) were measured, concurrently, multiple times before and during treatment. We examined T25FW speed variability within and between visits, correlations of T25FW speed with MSWS-12 score, and changes in MSWS-12 (mean scores, effect sizes) associated with percent T25FW changes. RESULTS: T25FW speed variability was small (within- and between-visit averages = 7.2%-8.7% and 14.4%-16.3%). Correlations between T25FW and MSWS-12 values were low (-0.20 to -0.30), but relatively stronger between their change values (-0.33 to -0.41). Speed improvements of >20%, and possibly 15%, were associated with clinically meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria. CONCLUSIONS: This study builds on existing research and provides direct evidence that improvements in T25FW speed of ≥ 20% are meaningful to people with MS. The dalfampridine data enabled examinations previously not possible, including spontaneous and induced speed changes, speed change anchored to change in self-reported walking ability, and a profile of speed changes. Results support the T25FW as a clinically meaningful outcome measure for MS clinical trials.
Original language | English |
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Pages (from-to) | 1509-1517 |
Number of pages | 0 |
Journal | Neurology |
Volume | 80 |
Issue number | 16 |
DOIs | |
Publication status | Published - 16 Apr 2013 |
Keywords
- 4-Aminopyridine
- Adult
- Aged
- Clinical Trials
- Phase III as Topic
- Female
- Gait
- Gait Disorders
- Neurologic
- Humans
- Male
- Meta-Analysis as Topic
- Middle Aged
- Multiple Sclerosis
- Neurologic Examination
- Potassium Channel Blockers
- Randomized Controlled Trials as Topic
- Reproducibility of Results
- Walking