Table 3.
Other secondary outcomes
| Placebo (95% CI) |
Perampanel 4 mg (95% CI) |
Perampanel 8 mg (95% CI) |
Perampanel 4 mg vs. Placebo (95% CI) |
p value | Perampanel 8 mg vs. Placebo (95% CI) |
p value | |
|---|---|---|---|---|---|---|---|
| Changes in ALSFRS-R score | |||||||
| At 4 weeks from baseline, n | − 1.3 (− 2.7 to –0.1), 22 | − 1.3 (− 2.6 to − 0.0), 20 | − 2.8 (− 4.2 to − 1.4), 21 | − 0.0 (− 1.5 to 1.5) | 0.9899 | − 1.5 (− 3.0 to 0.0) | 0.0526 |
| At 12 weeks from baseline, n | − 1.9 (− 3.5 to − 0.4), 21 | − 3.0 (− 4.5 to − 1.5), 18 | − 5.2 (− 6.9 to − 3.5), 16 | − 1.1 (− 3.0 to 0.8) | 0.2495 | − 3.3 (− 5.2 to − 1.4) | 0.0012 |
| At 24 weeks from baseline, n | − 5.0 (− 7.2 to − 2.8), 21 | − 6.1 (− 8.5 to − 3.6), 15 | − 7.4 (− 10.1 to − 4.7), 12 | − 1.1 (− 4.2 to 2.1) | 0.4953 | − 2.4 (− 5.7 to 0.9) | 0.1532 |
| At 36 weeks from baseline, n | − 7.6 (− 10.8 to − 4.3), 19 | − 9.6 (− 13.1 to − 6.0), 14 | − 14.1 (− 18.1 to − 10.1), 10 | − 2.0 (− 6.7 to 2.7) | 0.3951 | − 6.6 (− 11.6 to − 1.6) | 0.0112 |
| At 48 weeks from baseline, n | − 9.0 (− 13.1 to − 4.8), 18 | − 13.4 (− 18.0 to − 8.8), 14 | − 17.4 (− 22.7 to − 12.1), 7 | − 4.5 (− 10.6 to 1.6) | 0.1476 | − 8.4 (− 15.0 to − 1.8) | 0.0145 |
| Total ALSFRS-R scorea | |||||||
| At 4 weeks | 38.3 (36.3 to 40.3) | 38.8 (36.9 to 40.7) | 37.1 (35.1 to 39.1) | 0.5 (− 1.7 to 2.7) | 0.6722 | − 1.3 (− 3.4 to 0.9) | 0.2484 |
| At 12 weeks | 37.7 (35.7 to 39.7) | 37.1 (35.1 to 39.0) | 34.8 (32.6 to 36.9) | − 0.6 (− 2.9 to 1.7) | 0.5813 | − 2.9 (− 5.2 to − 0.6) | 0.0142 |
| At 24 weeks | 34.6 (32.1 to 37.1) | 34.0 (31.4 to 36.7) | 32.7 (29.7 to 35.6) | − 0.6 (− 3.9 to 2.8) | 0.7325 | − 1.9 (− 5.4 to 1.5) | 0.2665 |
| At 36 weeks | 32.1 (28.7 to 35.4) | 30.9 (27.3 to 34.5) | 26.3 (22.2 to 30.3) | − 1.2 (− 5.9 to 3.5) | 0.6150 | − 5.8 (− 10.8 to − 0.9) | 0.0225 |
| At 48 weeks | 30.7 (26.6 to 34.8) | 27.2 (22.8 to 31.7) | 23.6 (18.4 to 28.9) | − 3.5 (− 9.3 to 2.4) | 0.2351 | − 7.1 (− 13.5 to − 0.7) | 0.0315 |
ALS amyotrophic lateral sclerosis, ALSFRS-R ALS functional rating scale-revised
Analyses are based on date from the intention-to-treat population for all end points
aNumbers of patients at each week are same as those in the changes in ALSFRS-R scores