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RECRUITING
NCT04814381
PHASE4

Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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

Interventions

DRUG

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