Table 2 Preventive trials that feature changes in headache frequency from baseline to 2-weeks, ≥50% responder rates, and adverse events
From: Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions
Trial and year | Treatment | ECH | Baseline frequency active Rx per week ± SD | Rx reduction to week 2 ± SD | Baseline frequency placebo per week ± SD | Placebo reduction to week 2 ± SD | Active Treatment 50% response | Placebo 50% resp |
|---|---|---|---|---|---|---|---|---|
Goadsby 2019 [30] | Galcanezumab | All | 17.3 ± −10 | −8.8 ± 12.1, n = 57 | 17.8+/− 10.1 | − 4.5 ± 10.5, n = 49 | 39%, n = 57 | 25%, n = 49 |
Leone 1996 [16] | Melatonin | 90% | 23.1 | − 12.7 ± 16.0, n = 10 | 16.73 | 0.8 ± 11.4, n = 10 | NA | NA |
Leone 2000 [14] | Verapamil | All | 13.4 | −9.2, n = 15 | 9.59 | 1.7, n = 15 | 80%, n = 15 | 0%, n = 15 |
Saper 2002 [31] | Intranasal civamide | ECH | 12.5 | −8.4 ± 9.1, n = 18 | 10.8 | −3.6 ± 8.7 n = 10 | NA | NA |
Tronvik 2013 [7] | Candesartan | ECH | 14.3 ± 9.2 | −8.7, n = 19 | 16.8 | −6.2, n = 13 | 63%, n = 19 | 46%, n = 13 |