Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)
Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache
University Hospital, Clermont-Ferrand
90 participants
Sep 15, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age >= 18 years
- Chronic cluster headache diagnosis made according to ICHD-3 criteria
- A mean of at least 2 attacks/day during the 14 days before infusion
- Insufficient efficacy or intolerance or contra-indication to the use of the 3 main validated treatments (verapamil, lithium and sub-occipital steroids injections)
- Stable preventive treatment for at least 7 days before infusion
Exclusion Criteria5
- Pregnant or lactating woman
- Contra-indication to ketamine use (uncontrolled high blood pressure, stoke history, severe cardiac failure)
- Ketamine use during the previous year
- Hypersensitivity to the product or their metabolites
- Severe renal insufficiency (creatinine clearance < 30ml/min)
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Interventions
A single infusion will be performed over 2 hours with 90 days follow-up.
Locations(14)
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NCT04814381