Status:
RECRUITING
Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Refractory Chronic Cluster Headache
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04814381
Start Date
September 15 2021
End Date
December 1 2026
Last Update
July 16 2025
Active Locations (14)
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1
CH Annecy Genevois
Annecy, France, 74370
2
Polyclinique Jean Villar
Bruges, France, 33520
3
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
CHRU De Lille
Lille, France, 59000