|
Outcomes
|
Baseline
|
Administration
|
|---|
|
Third
|
Sixth
|
|---|
|
Reduction from baseline in MHD
|
|
≥ 30%
| |
49 (70)
|
56 (80)
|
|
≥ 50%
| |
37 (53)
|
49 (70)
|
|
≥ 75%
| |
13 (18)
|
18 (26)
|
|
Response after dose increase in non-responder patients
|
–
|
–
|
6/21 (29)
|
|
MHD
|
21.1 ± 0.7
|
11.4 ± 0.9*
|
8.9 ± 0.7*
|
|
Conversion from chronic to episodic migraine
|
–
|
46 (66)
|
49 (70)
|
|
Conversion from medication overuse to non-overuse
|
–
|
40 (57)
|
43 (62)
|
|
Pain intensity (NRS)
|
8.6 ± 0.1
|
8.1 ± 0.1*
|
7.9 ± 0.1*
|
|
MIDAS
|
108.1 ± 11.2
|
54.5 ± 11.4*
|
51.0 ± 9.7*
|
|
HIT-6
|
65.9 ± 1.2
|
60.7 ± 1.2*
|
59.5 ± 1.4*
|
|
MSQ
|
62.7 ± 7.5
|
42.0 ± 7.6*
|
41.5 ± 7.7*
|
|
BDI-II
|
17.0 ± 1.4
|
13.2 ± 1.5
|
11.2 ± 1.6*
|
|
HDRS
|
14.3 ± 0.9
|
12.3 ± 1.5
|
10.5 ± 1.2*
|
|
HARS
|
17.1 ± 1.2
|
15.1 ± 1.7
|
13.2 ± 1.6*
|
|
PCS
|
33.2 ± 1.3
|
24.9 ± 1.8*
|
25.8 ± 2.1*
|
|
MOS Sleep Scale
|
24.7 ± 0.7
|
24.2 ± 0.8
|
22.9 ± 1.1*
|
|
ASC-12
|
6.7 ± 0.7
|
5.5 ± 0.8*
|
4.8 ± 0.8*
|
|
MIG-SCOG
|
9.9 ± 0.6
|
8.6 ± 0.6
|
8.8 ± 0.8
|
- Values are mean ± standard error (SE) or number (%)
- * statistically significant difference (in comparison with baseline)
- ASC-12 Allodynia Symptom Checklist-12, BDI II Beck Depression Inventory II, HARS, Hamilton Anxiety Rating Scale, HDRS Hamilton Depression Rating Scale, HIT-6 headache impact test-6, MIDAS migraine disability assessment scale, MIG-SCOG MIGraine attacks - Subjective COGnitive impairments scale, MHD monthly headache days, MOH medication overuse headache, MOS Medical Outcomes Study, MSQ migraine-specific quality-of-life questionnaire, NRS numerical rating scale, PCS Pain Catastrophizing Scale
