Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)
KETALGIA
Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache
2 other identifiers
interventional
90
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2021
Longer than P75 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 16, 2025
October 1, 2024
5 years
March 18, 2021
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weekly attacks between day 7 - day 13 period compared to the pre-treatment period
Evaluate the efficacy of a single infusion of ketamine combined with magnesium sulfate compared to a control group receiving hydroxyzine (active placebo) in terms of weekly attacks between day 7 and day 13 period and pre-treatment period
pre-treatment period and day 7-day 13 post-treatment period
Secondary Outcomes (22)
Proportion of 30% responders
day 7 to day 90
Proportion of 50% responders
day 7 to day 90
Proportion of 75% responders
day 7 to day 90
week by week attacks frequency
day 0 to day 90
patient global impression of change (PGIC)
Day 15
- +17 more secondary outcomes
Study Arms (2)
Ketamine + Magnesium
EXPERIMENTALpatients 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%.
Control
ACTIVE COMPARATORpatients 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
Interventions
A single infusion will be performed over 2 hours with 90 days follow-up.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
CH Annecy Genevois
Annecy, 74370, France
Polyclinique Jean Villar
Bruges, 33520, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHRU De Lille
Lille, 59000, France
Hospices civils de Lyon, Hôpital Pierre Wertheimer
Lyon, 69500, France
AP-HM Marseille
Marseille, 13005, France
Clinique Beau Soleil
Montpellier, 34070, France
CHU de Montpellier
Montpellier, 34295, France
CHU Nantes, Hopital Nord Laennec
Nantes, 44000, France
Hôpital Lariboisière
Paris, 75010, France
CHU Rouen
Rouen, 76100, France
Hopital de Hautepierre
Strasbourg, 67098, France
Hopital Pierre Paul Riquet
Toulouse, 31059, France
CHU Grenoble-Alpes
Voiron, 38500, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier MOISSET
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- infusion will be prepared by a nurse that is not blinded to the treatment and will not take part to patient evaluation. Active and control treatments are of transparent colour and will not be recognisable.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 24, 2021
Study Start
September 15, 2021
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 16, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share