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Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)
Sponsor: University Hospital, Clermont-Ferrand
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.
Official title: Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2021-09-15
Completion Date
2026-12
Last Updated
2025-07-16
Healthy Volunteers
No
Conditions
Interventions
Ketamine + Magnesium sulfate (drug combination)
A single infusion will be performed over 2 hours with 90 days follow-up.
Locations (14)
CH Annecy Genevois
Annecy, France
Polyclinique Jean Villar
Bruges, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHRU De Lille
Lille, France
Hospices civils de Lyon, Hôpital Pierre Wertheimer
Lyon, France
AP-HM Marseille
Marseille, France
Clinique Beau Soleil
Montpellier, France
CHU de Montpellier
Montpellier, France
CHU Nantes, Hopital Nord Laennec
Nantes, France
Hôpital Lariboisière
Paris, France
CHU Rouen
Rouen, France
Hopital de Hautepierre
Strasbourg, France
Hopital Pierre Paul Riquet
Toulouse, France
CHU Grenoble-Alpes
Voiron, France