Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    90
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 1 October 2021

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 4.32.4 before treatment to 1.31.0 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.

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 4.32.4 before treatment to 1.31.0 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.

Details
Condition Refractory Chronic Cluster Headache
Treatment Ketamine + Magnesium sulfate (drug combination)
Clinical Study IdentifierNCT04814381
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on1 October 2021

Eligibility

Yes No Not Sure

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

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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