|
EDSS
|
Placebo N = 17
|
AP N = 20
|
p
|
|---|
|
Baseline median EDSS
|
6.0 (2.5–7.0)
|
6.0 (3.5–7.5)
|
0.92
|
|
Final median EDSS
|
6.5 (2.0–8.0)
|
6.0 (3.0–7.5)
|
0.24
|
|
Baseline mean EDSS
|
5.7 ± 1.3
|
5.8 ± 1.1
|
0.93
|
|
Final mean EDSS
|
6.2 ± 1.3
|
5.8 ± 1.3
|
0.43
|
|
Mean EDSS change
|
+ 0.35 (95% CI, −0.75 - 0.05)
|
−0.03 (95% CI, − 0.4 - 0.4)
|
0.04a
|
|
Other efficacy outcomes
|
PlaceboN = 17
|
APN = 20
|
p
|
|
mean change (95% CI)
|
mean change (95% CI)
|
|
SDMT
|
0.49 (0.05–0.92)
|
0.23 (−0.13–0.59)
|
0.36
|
|
PASAT
|
0.28 (−0.57–1.09)
|
0.22 (− 0.44–0.89)
|
0.92
|
|
9HPT
|
0.01 (−2.18–2.16)
|
−1.55 (−3.65–0.54)
|
0.32
|
|
T25FW
|
1.58 (−5.39–8.56)
|
−1.19 (−7.15–4.77)
|
0.56
|
|
MSFC
|
0.05 (−0.19–0.29)
|
0.11 (− 0.62–0.29)
|
0.69
|
|
RNFL
|
−9.2 (− 12.9–5.5)
|
−7.3 (− 11.2–3.3)
|
0.47
|
- aAdjusted model (baseline EDSS as a covariate); the mean difference between AP and placebo was 0.63
- SMDT: symbol digit modalities test; PASAT Paced auditory serial addition test; 9HPT Nine-hole peg test; T25FW Timed 25-ft walk; MSFC Multiple sclerosis functional composite; RNFL Retinal nerve fibre layer. The results from GLM were adjusted for baseline MSFC
