41
64000-00120 Rev 3
Table 10. PRESTO Key Efficacy End Points (Double-blind Period; ITT Population; N = 243)
1
No rescue medication use through 120 min after treatment completion for the first treated migraine attack; the
repeated-measures analysis used generalized linear mixed effects regression models, both with adjustment for the
participants’ baseline pain score, use of preventive therapies, and presence of aura;
2
Post hoc analysis;
3
No rescue
medication use through 120 min after treatment completion for the first treated migraine attack. Patients with mild
pain at both baseline and 30/60/120 minutes were not considered responders; p-values were derived from the
Chi-square test or Fisher’s exact test, as appropriate;
4
p-Values were derived from 2-sample t tests;
5
For patients
who had ≥2 treated migraine attacks.
30 Min
60 Min
120 Min
gammaCore
Sham
gammaCore Sham gammaCore
Sham
Primary endpoint (pain-free) – logistic regession
1
%
12.7 4.2 21.0 10.0 30.4 19.7
95% CI
7.2, 21.6
1.7, 9.6
14.1, 30.1
5.6, 17.4 22.2, 39.9 13.0, 28.6
p-Value 0.012 0.023 0.067
30, 60, and 120 minutes – repeated-measures
1,2
Odds Ratio
-
-
2.3
95% CI
-
-
1.2, 4.4
p-Value -
- 0.012
Secondary endpoint (mild/no pain)
3
%
26.7 18.7 35.8 24.4 40.8 27.6
95% CI
19.0, 35.5 12.2, 26.7
27.3, 45.1
17.1, 33.0 32.0, 50.2 20.0, 36.4
p-Value 0.138 0.052 0.030
Mean percentage change in pain intensity
2,4
%
−18.1
−5.2
−25.4
−7.7
−34.8
−5.4
95% CI
−28.0, −8.3 −14.8, 4.3 −36.7, −14.1
−19.5, 4.0 −45.9, −23.7 −21.7, 11.0
p-Value 0.064 0.033 0.004
≥50% pain-free responder rate
2,3,5
%
-
-
-
- 32.4 18.2
95% CI
-
-
-
-
23.6, 42.2
11.2, 27.2
p-Value -
- 0.020
≥50% responder rate (mild/no pain)
3,5
%
-
-
-
- 47.6 32.3
95% CI
-
-
-
-
37.8, 57.6 23.3, 42.5
p-Value -
- 0.026
