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CompletedPhase 4

Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

NCT04814381 · KETALGIA · University Hospital, Clermont-Ferrand

Closed to entry
Status
Not accepting participants
Phase 4
Phase
93
Target enrolment
14
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in weekly attacks between day 7 - day 13 period compared to the pre-treatment period

    Measured over pre-treatment period and day 7-day 13 post-treatment period

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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)

Where

14 study sites

FacilityCityRegionCountry
CH Annecy GenevoisAnnecy—France
Polyclinique Jean VillarBruges—France
CHU de Clermont-FerrandClermont-Ferrand—France
CHRU De LilleLille—France
Hospices civils de Lyon, Hôpital Pierre WertheimerLyon—France
AP-HM MarseilleMarseille—France
Clinique Beau SoleilMontpellier—France
CHU de MontpellierMontpellier—France
CHU Nantes, Hopital Nord LaennecNantes—France
Hôpital LariboisièreParis—France
CHU RouenRouen—France
Hopital de HautepierreStrasbourg—France
Hopital Pierre Paul RiquetToulouse—France
CHU Grenoble-AlpesVoiron—France

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04814381 on ClinicalTrials.gov →

Last updated in the registry 2026-05-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from University Hospital, Clermont-Ferrand →