Table 2.
Primary and secondary efficacy endpoints: change in the final 3TUG times and W‐SAS score upon withdrawal of study drug
| Study group | Score | Taper‐to‐placebo, n = 18, n (%) | Continuous 3,4‐DAP, n = 14, n (%) |
|---|---|---|---|
| 3TUG change | No change or faster | 5 (27.8) | 14 (100) |
| >30% Slower | 13 (72.2) | 0 (0) | |
| P < 0.0001a | |||
| Final W‐SAS | Much much weaker (−3) | 10 (55.6) | 1 (7.1) |
| Much weaker (−2) | 6 (33.3) | 1 (7.1) | |
| Somewhat weaker (−1) | 1 (5.6) | 1 (7.1) | |
| About the same (0) | 1 (5.6) | 9 (64.3) | |
| Somewhat stronger (+1) | 0 (0.0) | 1 (7.1) | |
| Much stronger (+2) | 0 (0.0) | 1 (7.1) | |
| Much much stronger (+3) | 0 (0.0) | 0 (0.0) | |
| P < 0.0001b | |||
3,4‐DAP, 3,4‐diaminopyridine base; 3TUG, triple timed up‐and‐go; CMH, Cochrane‐Mantel‐Haenszel; W‐SAS, LEM‐related weakness self‐assessment scale.
a
Fisher's exact test.
b
CMH test for categorical data.