Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)
NCT ID: NCT04814381
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2021-09-15
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ketamine + Magnesium
patients in the experimental group will receive 0.5mg/kg of ketamine over 2 hours, diluted in 50cc of NaCl 0.9% and 3g of magnesium sulfate over 30 minutes diluted in 250cc of NaCl 0.9%.
Ketamine + Magnesium sulfate (drug combination)
A single infusion will be performed over 2 hours with 90 days follow-up.
Control
patients in the control group will receive 25mg of hydroxyzine over 2 hours, diluted in 50cc of NaCl 0.9% and 250cc of NaCl 0.9% over 30 minutes
Ketamine + Magnesium sulfate (drug combination)
A single infusion will be performed over 2 hours with 90 days follow-up.
Interventions
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Ketamine + Magnesium sulfate (drug combination)
A single infusion will be performed over 2 hours with 90 days follow-up.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Xavier MOISSET
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-003604-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RBHP 2020 MOISSET
Identifier Type: -
Identifier Source: org_study_id
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