This placebo-controlled, randomised trial (n=90) investigates the efficacy of a single infusion of ketamine combined with magnesium sulphate in treating refractory chronic cluster headache (CCH).
Chronic cluster headache is a rare primary headache disorder characterised by frequent attacks lasting over a year with little to no remission. The study aims to confirm previous findings suggesting that the combination of ketamine and magnesium can reduce the frequency of attacks in patients with drug-resistant CCH.
Participants will be randomly assigned to receive either the experimental treatment or a control, with outcomes measured in terms of the proportion of patients experiencing at least a 50% reduction in daily attacks. The study is conducted across multiple locations in France and is estimated to be completed by December 2024.
Trial Details
Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting < 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks. Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.NCT Number NCT04814381