Ketamine and Magnesium for treating chronic cluster headaches
Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache
This study is testing if a mix of ketamine and magnesium can help people with chronic cluster headaches have fewer attacks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 10 sites (Annecy and 9 other locations) |
| Trial ID | NCT04814381 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combination of ketamine and magnesium sulfate in reducing the frequency of attacks in patients suffering from refractory chronic cluster headache (CCH). The study aims to confirm previous findings that showed a significant reduction in daily headache attacks following a single infusion of this drug combination. Participants will be monitored for changes in the number of attacks two weeks prior to the infusion and one week after. The study is placebo-controlled to ensure the reliability of the results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with chronic cluster headache and experience at least two attacks per day.
Not a fit: Patients who are pregnant, have contraindications to ketamine, or have severe renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of debilitating headache attacks for patients with chronic cluster headaches.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Annecy and 9 other locations
- CH Annecy Genevois — Annecy, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHRU De Lille — Lille, France (Recruiting)
- Hospices civils de Lyon, Hôpital Pierre Wertheimer — Lyon, France (Recruiting)
- AP-HM Marseille — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU Nantes, Hopital Nord Laennec — Nantes, France (Recruiting)
- Hôpital Lariboisière — Paris, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
- Hopital de Hautepierre — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Xavier MOISSET — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.