Clinical TrialHeadache Disorders (Cluster & Migraine)KetaminePlaceboRecruiting

Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

This placebo-controlled, randomised trial (n=90) investigates the efficacy of a single infusion of ketamine combined with magnesium sulphate in treating refractory chronic cluster headache (CCH).

Target Enrollment
90 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial comparing a single infusion of ketamine (0.5 mg/kg over 2 hours) plus magnesium sulfate (3 g over 30 minutes) versus an active comparator (hydroxyzine 25 mg) in patients with refractory chronic cluster headache.

Primary outcome compares mean daily attack frequency in the 14 days before infusion with days 7–8 after infusion; follow-up to 90 days to assess durability and safety.

Study Protocol

Preparation

sessions

Dosing

1 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine + Magnesium

experimental

Single infusion of ketamine combined with magnesium sulphate.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Ketamine 0.5 mg/kg infused over 2 hours diluted in 50 mL NaCl 0.9%.

  • Compound3 g
    via IV• single dose• 1 doses total

    Magnesium sulfate 3 g over 30 minutes diluted in 250 mL NaCl 0.9%.

Control

active comparator

Active comparator: hydroxyzine infusion.

Interventions

  • Placebo25 mg
    via IV• single dose• 1 doses total

    Hydroxyzine 25 mg infusion over 2 hours (active comparator).

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

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

Exclusion Criteria

  • 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 Details

Locations

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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