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Re-purposing of 2 well-known molecules (ketamine and magnesium sulfate) to treat a specific and excruciating type of pain (chronic cluster headache) in patients who are not relieved by currently recommended treatments
EU CTIS ID: 2024-518943-38-00
What this study is testing
Evaluate the efficacy of a single infusion of ketamine combined with magnesium sulfate compared to a control group receiving hydroxyzine (active placebo)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Diagnosis of chronic cluster headache according to ICHD-3 criteria
- Presence of at least 2 crises/24 hours on average during the 14 days preceding the ketamine infusion
- Insufficient effectiveness, intolerance or contraindication to the use of the 3 major treatments for the management of cluster headaches: verapamil, lithium and corticosteroids (oral or suboccipital injections)
- informed consent
You likely can't join if
- Pregnant or breastfeeding woman
- Contraindication to the use of ketamine
- Use of ketamine in the year preceding the study
- Severe renal failure
- Severe liver failure
- Implementation or modification of an analgesic treatment (background treatments) in the 7 days preceding the infusion
See the full eligibility criteria
- Age ≥ 18 years
- Diagnosis of chronic cluster headache according to ICHD-3 criteria
- Presence of at least 2 crises/24 hours on average during the 14 days preceding the ketamine infusion
- Insufficient effectiveness, intolerance or contraindication to the use of the 3 major treatments for the management of cluster headaches: verapamil, lithium and corticosteroids (oral or suboccipital injections)
- informed consent
- Pregnant or breastfeeding woman
- Contraindication to the use of ketamine
- Use of ketamine in the year preceding the study
- Severe renal failure
- Severe liver failure
- Implementation or modification of an analgesic treatment (background treatments) in the 7 days preceding the infusion
- Patient under legal protection measure
- Addictive behaviors
- Corrected QT > 450ms
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.