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Table 5. ACT2 Key End Points (mITT Population Unless Otherwise Indicated)
Abbreviations: cCH, chronic cluster headache; CH, cluster headache; CI, confidence interval; eCH, episodic cluster
headache; ITT, intent-to-treat; nVNS, non invasive vagus nerve stimulation; SD, standard deviation; SE, standard error.
a
No rescue medication use at any point after treatment initiation for the attack.
b
P values are from generalized estimating equations model, which was adjusted for site for the total cohort and
cCH subgroups but not adjusted for site in the eCH subgroup; odds ratio >1 favors nVNS.
c
P values are from the Wilcoxon rank sum test stratified by study site.
d
P values were derived from 2-sided t tests.
e
P values were determined from the chi-square or Fisher exact test, as appropriate.
f
P values were derived from the Cochran-Mantel-Haenszel test stratified by site.
All Subjects
eCH Cohort
cCH Cohort
nVNS Sham nVNS Sham nVNS Sham
End Point
(n=48)
(n=44)
(n=14)
(n=13)
(n=34)
(n=31)
Primary end point (all subjects)
Attacks that were pain free
13.5
11.5
47.5
6.2
4.8
12.9
at 15 min, % (n/N)
a
(67/495) (46/400) (48/101) (5/81) (19/394) (41/319)
Odds ratio (95% CI)
1.22 (0.42, 3.51)
9.19 (1.77, 47.80)
0.41 (0.13, 1.30)
P value
b
0.71 <0.01 0.13
Secondary end points (all subjects)
Percentage of attacks per
subject that responded at
42.7±37
27.6±33
57.5±40
25.5±37
36.6±34
28.5±31
30 min, mean±SD
a
nVNS vs sham
difference, mean±SE
15.1±7 32.0±15 8.1±8
P value
c
0.05 0.07 0.34
Change in pain level
at 15 min,
a
mean±SE
-1.3±0.2 -0.9±0.1 -1.7±0.4 -0.6±0.2 -1.2±0.2 -1.0±0.2
No. (observed cases)
36
31
11
8
25
23
P value
d
0.06 0.01 0.52
Other end points (all subjects)
Subjects who achieved
responder status at 30 min 19 (39.6) 6 (13.6)
9 (64.3)
2 (15.4)
10 (29.4)
4 (12.9)
for ≥50% of treated attacks,
No. (%)
a
P value
e
0.01 0.01 0.11
Subjects who achieved
responder status at 15 min 18 (37.5) 13 (29.5)
7 (50.0)
2 (15.4)
11 (32.4) 11 (55.0)
for their first treated attack,
No. (%)
a
P value
f
0.35 0.06 0.79
