Table 1.
Baseline characteristics of randomised participants
| Amiloride (n=111) | Fluoxetine (n=111) | Riluzole (n=111) | Placebo (n=112) | Total (n=445) | ||
|---|---|---|---|---|---|---|
| Age (years) | 55·2 (49·0–60·5) | 55·5 (50·7–60·2) | 55·1 (49·7–59·2) | 56·4 (49·2–60·4) | 55·5 (49·7–60·3) | |
| Male sex | 36 (32%) | 37 (33%) | 37 (33%) | 37 (33%) | 147 (33%) | |
| Female sex | 75 (68%) | 74 (67%) | 74 (67%) | 75 (67%) | 298 (67%) | |
| Expanded Disability Status Scale score | 6·0 (5·5–6·5) | 6·0 (5·5–6·5) | 6·0 (5·5–6·5) | 6·0 (5·5–6·5) | 6·0 (5·5–6·5) | |
| Time since first symptoms (years) | 20 (13–30) | 21 (16–29) | 21 (16–26) | 19 (13–29) | 21 (15–29) | |
| Time since progression (years) | 6 (4–11) | 5 (3–10) | 6 (4–10) | 5 (3–10) | 6 (3–10) | |
| Beck Depression Index II score | 6 (4–9) | 6 (3–10) | 7 (4–12) | 7 (4–12) | 6 (4–11) | |
| Multiple Sclerosis Functional Composite score (Z-score) | −0·19 (1·19) | −0·02 (0·60) | −0·09 (0·95) | −0·00 (0·91) | −0·07 (0·93) | |
| Paced Auditory Serial Addition Test | 39·0 (13·7) | 36·6 (15·2) | 36·9 (16·0) | 41·5 (13·9) | 38·5 (14·8) | |
| Timed 25-Foot Walk (s) | 12·0 (8·0–23·0) | 11·0 (8·5–18·0) | 11·4 (8·6–18·4) | 10·6 (7·8–15·0) | 11·2 (8·4–18·6) | |
| 9-Hole Peg Test (s−1) | 0·03 (0·01) | 0·03 (0·01) | 0·03 (0·01) | 0·03 (0·01) | 0·03 (0·01) | |
| Symbol Digit Modalities Test | 43·9 (12·4) | 44·1 (11·4) | 44·5 (13·1) | 44·1 (12·8) | 44·2 (12·4) | |
| High contrast (100%) visual acuity | 50·1 (11·2) | 50·8 (10·8) | 48·5 (14·8) | 50·4 (12·7) | 49·9 (12·5) | |
| Sloan low contrast visual acuity | ||||||
| 5% contrast | 32·6 (13·4) | 32·9 (12·8) | 30·0 (16·1) | 33·9 (14·6) | 32·4 (14·3) | |
| 2·5% contrast | 19·1 (12·7) | 17·6 (12·4) | 18·8 (14·2) | 20·8 (14·0) | 19·1 (13·3) | |
| 1·25% contrast | 8·2 (10·7) | 6·9 (9·6) | 7·1 (10·7) | 9·9 (11·9) | 8·0 (10·8) | |
| Multiple Sclerosis Impact Scale 29 items version 2 | ||||||
| Total score | 63·9 (13·4) | 65·0 (13·8) | 69·2 (15·0) | 66·1 (14·4) | 66·0 (14·3) | |
| Physical score | 48·0 (10·5) | 48·3 (10·4) | 51·0 (11·3) | 49·0 (11·2) | 49·1 (10·9) | |
| Psychological score | 15·9 (4·5) | 16·7 (4·8) | 18·2 (5·4) | 17·1 (5·0) | 17·0 (5·0) | |
| Multiple Sclerosis Walking Scale version 2 | 41·4 (9·2) | 41·1 (9·8) | 42·6 (9·3) | 41·6 (9·9) | 41·7 (9·5) | |
| Neurological Fatigue Index | ||||||
| Summary score | 18·0 (4·2) | 17·4 (3·9) | 19·1 (4·8) | 17·8 (3·9) | 18·1 (4·2) | |
| Physical score | 15·1 (3·8) | 14·7 (3·9) | 15·9 (4·3) | 14·7 (3·7) | 15·1 (3·9) | |
| Cognitive score | 6·5 (2·2) | 6·2 (2·2) | 7·1 (2·3) | 6·3 (2·4) | 6·5 (2·3) | |
| Diurnal score | 10·1 (2·8) | 9·6 (2·9) | 10·2 (3·1) | 9·7 (2·5) | 9·9 (2·8) | |
| Nocturnal score | 7·7 (2·0) | 7·6 (2·5) | 8·2 (2·8) | 8·0 (2·3) | 7·9 (2·4) | |
| EQ-5D-5L | ||||||
| Index score | 0·68 (0·17) | 0·70 (0·16) | 0·66 (0·17) | 0·67 (0·18) | 0·68 (0·17) | |
| VAS score | 66·1 (16·9) | 67·5 (19·5) | 61·7 (21·0) | 65·2 (20·3) | 65·2 (19·5) | |
| At least one relapse in past 2 years | 15 (14%) | 9 (8%) | 6 (5%) | 12 (11%) | 42 (9%) | |
| Baseline normalised brain volume (mL) | 1432·2 (84·2) | 1413·1 (82·4) | 1414·2 (74·8) | 1431·0 (91·1) | 1422·6 (83·6) | |
| T2 lesion volume (mL) | 10·1 (3·5–17·4) | 10·7 (4·8–20·4) | 10·5 (3·8–19·6) | 10·6 (4·4–17·6) | 10·4 (4·1–18·6) | |
Data presented are n (%), mean (SD), or median (IQR). No data were missing for the 9-Hole Peg Test, Multiple Sclerosis Impact Scale 29 items version 2, and EQ-5D-5L (VAS score); for the remaining variables, varying amounts of data were missing up to a maximum of 12 patients overall (maximum five for amiloride, two for fluoxetine, three for riluzole, and four for placebo). EQ-5D-5L=EuroQol five dimensions five levels. VAS=visual analogue scale.