Table 1 RCTs on preventive treatment for cluster headache
Treatment | Type of study | Parti-cipants | Summary of efficacy | Effect | Clinical notes |
|---|---|---|---|---|---|
Verapamil | Double-blind RCT from 2000 (360 mg/day) | 30 eCH patients | 2.week: 12/15 (80%) has > 50% reduction in attack frequency compared with 0% in the placebo group | Moderate | First choice |
ECT monitoring mandatory | |||||
Study duration 19 days (5 days run in, 2 weeks treatment) | |||||
Mean attack frequency 0,6 in the verapamil group compared with 1,65 in the placebo group (p > 0,001) | |||||
Double-blind cross-over comparison between verapamil 360 mg/day and lithium 900 mg/day from 1990 | 30 cCH patients | 1st week of treatment: 50% on verapamil had a reduction in a non-specified headache index | |||
Study duration 23 weeks in total (Two 8 week-treatment periods without wash-out) | |||||
Lithium | Double-blind RCT from 1997 (800 mg/day) | 27 eCH patients | After 1 week no difference between groups (2/14 on lithium and 2/13 on placebo had cessation of attacks) | Moderate | Not suitable for short bouts and patients with poor compliance |
Study duration 7 days | |||||
ECG monitoring and blood samples mandatory | |||||
Double-blind cross-over comparison between verapamil 360 mg/day and lithium 900 mg/day from 1990 Study duration 23 weeks in total ( 2 8 week treatment periods without wash-out) | 30 cCH patients | 1st week of treatment: 50% on verapamil had a reduction in a non-specified headache index | |||
Topiramate | No RCTs | Inconclusive | Monitor mood changes | ||
cGRP antibody Galcanezumab | Double-blind multicenter RCT from 2019 (s.c.300 mg/month) Study duration: a prospective baseline period and an 8 week double-blind, placebo-controlled period | 106 eCH patients were randomized | 50% attack reduction in 71% patients receiving galcanezumab compared to 53% receiving placebo Mean weekly attack frequency across weeks 1 through 3 was 8.7 for galcanezumab and 5.2 for placebo (p = 0,04) | Moderate | Very few side effects and contra indications |
Double-blind multicenter RCT from 2020 (s.c. 300 mg/month) Study duration: A prospective baseline period, a 12-week double-blind, placebo-controlled treatment period, and a 52-week open-label period | 237 cCH were randomized | Mean change in weekly attack frequency was 4.6 placebo versus 5.4 galcanezumab (p = 0.334) | Not effective /Inconclu-sive (study design not optimal) | Very few side effects and contra indications Study halted before final inclusion |