Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Ketamine; Magnesium Sulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)