Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache

Who is this study for? Patients with refractory chronic cluster headache
What treatments are being studied? Ketamine+Magnesium sulfate
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Annecy Genevois
RECRUITING
Annecy
Polyclinique Jean Villar
RECRUITING
Bruges
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHRU De Lille
RECRUITING
Lille
Hospices civils de Lyon, Hôpital Pierre Wertheimer
RECRUITING
Lyon
AP-HM Marseille
RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
Clinique Beau Soleil
RECRUITING
Montpellier
CHU Nantes, Hopital Nord Laennec
RECRUITING
Nantes
Hôpital Lariboisière
RECRUITING
Paris
CHU Rouen
RECRUITING
Rouen
Hopital de Hautepierre
RECRUITING
Strasbourg
Hopital Pierre Paul Riquet
RECRUITING
Toulouse
CHU Grenoble-Alpes
NOT_YET_RECRUITING
Voiron
Contact Information
Primary
Lise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Time Frame
Start Date: 2021-09-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 90
Treatments
Experimental: 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%.
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov