RecruitingPhase 4NCT04814381

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

90 participants

Start Date

Sep 15, 2021

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

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

DRUGKetamine + 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

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NCT04814381