Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

Last updated: June 5, 2023
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

4

Condition

Headaches

Pain

Trigeminal Neuralgia

Treatment

Ketamine + Magnesium sulfate (drug combination)

Clinical Study ID

NCT04814381
RBHP 2020 MOISSET
2020-003604-14
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 mainvalidated treatments (verapamil, lithium and sub-occipital steroids injections)
  • Stable preventive treatment for at least 7 days before infusion

Exclusion

Exclusion Criteria:

  • 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)

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Ketamine + Magnesium sulfate (drug combination)
Phase: 4
Study Start date:
September 15, 2021
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • CH Annecy Genevois

    Annecy, 74370
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHRU De Lille

    Lille, 59000
    France

    Active - Recruiting

  • Hospices civils de Lyon, Hôpital Pierre Wertheimer

    Lyon, 69500
    France

    Active - Recruiting

  • AP-HM Marseille

    Marseille, 13005
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU Nantes, Hopital Nord Laennec

    Nantes, 44000
    France

    Active - Recruiting

  • CHU Nice

    Nice, 06000
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • CHU Rouen

    Rouen, 76100
    France

    Active - Recruiting

  • Hopital de Hautepierre

    Strasbourg, 67098
    France

    Active - Recruiting

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