TABLE 2.
Treatment effectiveness
| Screening period baseline (N = 95) | Week 12 (n = 95) | Week 24 (n = 86) | |
|---|---|---|---|
| ≥50% reduction in MMD, n (%) | |||
| No | – | 54 (56.8) | 43 (50.0) |
| Yes | – | 32 (33.7) | 30 (34.9) |
| Number missing | – | 9 (9.5) | 13 (15.1) |
| MMD | |||
| Mean (SD) | 15.7 (6.1) | 10.4 (7.7) | 9.7 (6.7) |
| Median (IQR) | 14.0 (11.2, 19.0) | 9.0 (4.0, 14.6) | 8.52 (4.7, 12.3) |
| Number missing, n (%) | 0 | 9 (9.5) | 13 (15.1) |
| MMD changes from baseline | |||
| Mean (SD) b | – | −4.9 (5.8) | −5.7 (6.1) |
| Median (IQR) | – | −4.6 (−8.0, −1.0) | −5.0 (−9.3, −1.8) |
| Number missing, n (%) | – | 9 (9.5) | 13 (15.1) |
| P‐GIC, n (%) | |||
| 1‐Very much improved | – | 11 (11.6) | 15 (17.4) |
| 2‐Much improved | – | 28 (29.5) | 20 (23.3) |
| 3‐Minimally improved | – | 23 (24.2) | 10 (11.6) |
| 4‐No change | – | 7 (7.4) | 5 (5.8) |
| 5‐Minimally worse | – | 2 (2.1) | 1 (1.2) |
| 6‐Much worse | – | 1 (1.1) | 0 (0.0) |
| Number missing | – | 23 (24.2) | 35 (40.7) |
| CGI‐S a , n (%) | |||
| 0‐Not assessed | 1 (1.1) | 5 (5.3) | 3 (3.5) |
| 1‐Normal, not at all ill | 28 (29.5) | 23 (24.2) | 21 (24.4) |
| 2‐Borderline mentally ill | 1 (1.1) | 16 (16.8) | 19 (22.1) |
| 3‐Mildly ill | 15 (15.8) | 22 (23.2) | 18 (20.9) |
| 4‐Moderately ill | 29 (30.5) | 23 (24.2) | 16 (18.6) |
| 5‐Markedly ill | 12 (12.6) | 3 (3.2) | 2 (2.3) |
| 6‐Severely ill | 7 (7.4) | 1 (1.1) | 1 (1.2) |
| 7‐Among the most extremely ill patients | 2 (2.1) | 1 (1.1) | 0 (0.0) |
| Number missing | 0 (0.0) | 1 (1.1) | 6 (7.0) |
| CGI‐I, n (%) | |||
| 0‐Not assessed | – | 2 (2.1) | 2 (2.3) |
| 1‐Very much improved | – | 24 (25.3) | 27 (31.4) |
| 2‐Much improved | – | 37 (38.9) | 25 (29.1) |
| 3‐Minimally improved | – | 17 (17.9) | 15 (17.4) |
| 4‐No change | – | 14 (14.7) | 9 (10.5) |
| 5‐Minimally worse | – | 0 (0.0) | 2 (2.3) |
| Number missing | – | 1 (1.1) | 6 (7.0) |
Abbreviations: CGI‐I, Clinical Global Impressions‐Improvement; CGI‐S, Clinical Global Impressions‐Severity; IQR, interquartile range; MMD, monthly migraine days; P‐GIC, Patient Global Impression of Change; SD, standard deviation.
a
CGI‐S was used to assess the severity of psychopathology related to migraine.
b
Changes from baseline were calculated only for patients where both the data at baseline and other timepoints (12 and 24 weeks) were available.