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Ketamine + Magnesium for Refractory Chronic Cluster Headache
NCT04814381Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2021
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Refractory Chronic Cluster Headache (rCCH)
01
Overview
Phase 4, randomised, double-blind trial of ketamine and magnesium sulfate in Refractory Chronic Cluster Headache (rCCH) (2 arms), sponsored by Centre Hospitalier Universitaire de Clermont-Ferrand. Primary endpoint: Change in weekly attacks compared to pre-treatment at 1 week. Started Sep 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ketamine + Magnesium
0.5mg/kg ketamine over 2 hours + 3g magnesium sulfate over 30 minutes
Control
25mg hydroxyzine over 2 hours + NaCl over 30 minutes
03
Who it enrols
Adults with refractory chronic cluster headache (>= 2 attacks/day) who failed verapamil, lithium, and sub-occipital steroids.
04
Endpoints
Primary
Change in weekly attacks compared to pre-treatment
Secondary
Change in weekly attacks compared to pre-treatment
Proportion of responders
Week by week attacks frequency
Patient Global Impression of Change
Infusion's safety
Proportion of patients necessitating rescue therapy
Treatment response according to initial magnesemia
Attacks treatment consumption
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