Skip to main content
. 2021 Jun 30;269(2):885–896. doi: 10.1007/s00415-021-10670-y

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