Greater occipital nerve injection with methylprednisolone as transitional therapy in episodic cluster headache: Results from an RCT

= 0.230). However, exploratory analysis of the secondary endpoints showed a lower verapamil dose in the first four weeks in the methylprednisolone group compared to placebo (227 ± 126 mg vs. 287 ± 107 mg; mean Δ 60 mg; 95% CI = -4 to -116), as was the median number of attacks at week 1 (7 (interquartile range = 2-11.75) vs. 10 (interquartile range = 6-17.5); 95% CI = -1.0 to -8.0), the mean attack intensity at week 1 (5.7 ± 1.9 vs. 6.6 ± 1.8; 95% CI = 0.0-1.8) and throughout the 12-week study period (5.0 ± 1.8 vs. 5.9 ± 1.9; 95% CI = 0.01-1.8), and the number of days with adverse events (455/2520 (18%) vs. 605/2850 (21%); p < 0.01). There were no serious AEs.ComclusionsThis study failed to establish its primary endpoint. However, exploratory analysis of the secondary endpoints revealed that GON injection with 80 mg of methylprednisolone at the beginning of a cluster headache episode followed by standard therapy verapamil is a safe transitional treatment that provides faster reduction in attack frequency and intensity than verapamil alone, decreases the mean verapamil dose over the first four weeks with consequently fewer adverse events in the first four weeks after the injection.Trial RegistrationThis study is registered on Clinicaltrials.gov with registration number NCT04014634 at 08-07-2019. First inclusion was on 30-07-2019.