TABLE 2.
Primary and key secondary end point results
| 3 months (n = 55) | 6 months (n = 54) | 9 months (n = 51) | 12 months (n = 48) | |
|---|---|---|---|---|
| Primary end point (mean (SD)[95% CI]) | ||||
| MmsHD change | −8.6 (3.9) [−7.6, −9.7] | −10.1 (4.7) [−8.8, −11.4] | −9.5 (4.7) [−8.3, −11.1] | −10.8 (4.0) [−9.5, −11.9] |
| p‐value a | <0.001 | <0.001 | <0.001 | <0.001 |
| Secondary end points (mean (SD) [95% CI], unless otherwise stated) | ||||
| MHD change | −8 (8.1) [−5.5, −9.6] | −10.5 (8.7) [−7.9, −12.8] | −9.8 (8.5) [−7.5, −12.3] | −13.0 (9.5) [−10.2, −15.7] |
| p‐value b | <0.001 | <0.001 | <0.001 | <0.001 |
| Crystal clear days change | 7.7 (7.7) [5.6, 9.8] | 10.3 (9) [7.8, 12.7] | 10.3 (8.8) [7.8, 12.8] | 13.1 (9.5) [9.6, 15.3] |
| p‐value b | <0.001 | <0.001 | <0.001 | <0.001 |
| Headache severity change (NRS) | −1.2 (1.5) [−0.8, −1.61] | −1.3 (1.6) [−0.8, −1.7] | −1 (1.6) [−0.5, −1.4] | −1.3 (1.7) [−0.9, −1.9] |
| p‐value a | <0.001 | <0.001 | <0.001 | <0.001 |
| Monthly analgesic days change | −3.4 (7.8) [−1.3, −5.5] | −4.0 (8.1) [−1.8, −6.2] | −4.4 (7.8) [−2.2, −6.6] | −4.3 (9.2) [−1.6, −6.9] |
| p‐value a | 0.002 | 0.001 | <0.001 | 0.002 |
| Monthly triptan days change | −0.3 (4.3) [−0.9, 1.5] | −0.8 (3.7) [−0.3, 1.8] | −0.9 (4) [−0.9, 1.8] | −1 (4.6) [−0.4, 2.4] |
| p‐value a | 0.615 | 0.183 | 0.498 | 0.153 |
| Responder rates moderate/severe headaches/all headache (%) | ||||
| ≥30% | 89%/44% | 91%/57% | 88%/57% | 98%/65% |
| ≥50% | 62%/25% | 69%/50% | 76%/29% | 85%/54% |
| ≥75% | 18%/5% | 39%/19% | 43%/10% | 52%/25% |
| Main patient reported outcomes, mean (SD) | ||||
| Monthly absenteeism days change | −4.7 (8.3) [−2.1, −6.5] | −7.0 (11.4) [−3.5, −9.6] | −6.7 (11.9) [−3.0, −9.6] | −7.1 (11.5) [−2.9, −9.5] |
| p‐value b | <0.001 | <0.001 | <0.001 | <0.001 |
| Monthly presenteeism days change | −10.8 (8.3) [−8.5, −13.1] | −12.3 (11.1) [−9.4, −15.2] | −11.2 (12.2) [−7.8, −14.6] | −12.7 (10.1) [−9.5, −15.5] |
| p‐value b | <0.001 | <0.001 | <0.001 | <0.001 |
| HIT‐6 score change | −6.1 (10) [−3.3, −9.0] | −7.7 (8.3) [−5.3, −10.1] | −6.9 (8.8) [−4.6, −9.6] | −7.6 (8.7) [−4.7, −10.0] |
| p‐value a | <0.001 | <0.001 | <0.001 | <0.001 |
| IIH symptoms, No. (%) | Baseline (n = 55) | 3 months (n = 55) | 6 months (n = 54) | 9 months (n = 51) | 12 months (n = 48) |
|---|---|---|---|---|---|
| Double vision | 21 (38%) | 22 (40%) | 5 (9%) | 7 (14%) | 12 (25%) |
| Blurred vision | 42 (76%) | 38 (69%) | 31 (57%) | 35 (69%) | 31 (65%) |
| Pulsatile tinnitus | 49 (89%) | 47 (85%) | 35 (65%) | 39 (77%) | 35 (73%) |
| Visual obscurations | 19 (35%) | 22 (40%) | 6 (11%) | 7 (14%) | 4 (8%) |
a
Paired t‐test compared to baseline.
b
Wilcoxon signed ranks test compared to baseline.
Abbreviations: CI, confidence interval; HIT‐6, headache impact test‐6; IIH, idiopathic intracranial hypertension; MHD, monthly total headache days; MmsHD, monthly moderate/severe headache days; NRS, numeric rating scale (0 = no pain to 10 = worst imaginable pain).