Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

KETALGIA : Evaluation of the effectiveness of a ketamine infusion combined with magnesium sulfate in the treatment of chronic refractory cluster headache

This UK-based study, called KETALGIA, is a Phase III clinical trial for people with chronic refractory cluster headache. This means it's for those with very severe and long-lasting cluster headaches that haven't responded well to other treatments. The main goal is to see if a special drip, or infusion, containing ketamine and magnesium can help reduce how often these debilitating headaches happen each week. The study will compare how frequently headaches occur after the treatment compared to before. Researchers will also look at other things like the intensity of headaches, how many people see a significant improvement, and any side effects. This involves a careful medical process to ensure safety and gather important information about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Hospital Of Clermont-Ferrand

Enrolment target

Start

03 Dec 2024

refractory chronic cluster headache

What is this study about?

This study, called KETALGIA, is looking into a new way to treat a specific type of very severe headache called 'chronic refractory cluster headache'. This means you have ongoing cluster headaches that are very painful and haven't gotten better with other treatments you've tried.

The researchers want to see if a special drip (infusion) given to patients might help. This drip contains two medicines: ketamine and magnesium. They are trying to find out if this combination can reduce how often these painful headaches happen each week. They will carefully compare how many headaches people have after they receive the infusion with how many they had before.

This is a 'Phase III' study, which means it's a more advanced stage of research. It aims to confirm if the treatment is effective and safe for a larger group of people. Understanding if this treatment works could be a big step forward for people living with these difficult-to-treat headaches.

Key takeaways

Targets chronic, severe cluster headaches that haven't responded to other treatments.
Investigates a ketamine and magnesium infusion delivered via a drip.
Aims to reduce how often cluster headaches occur each week.
Involves tracking headache frequency, intensity, and overall well-being.
Open to adults aged 18 and over.
You have the right to withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you must be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

Crucially, you would need to have been diagnosed with 'chronic refractory cluster headache'. This means your cluster headaches are ongoing and severe, and they haven't gotten better with the usual treatments.

There will be other medical checks performed by the study team to make sure it's safe for you to take part and that the study is right for you. They will review your medical history carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Have I been diagnosed with chronic refractory cluster headache?
Do my cluster headaches occur often and not get better with current treatments?
Am I willing to have a medical team review my health history?
Am I able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a special drip (infusion) containing either the study treatment (ketamine and magnesium) or a 'dummy' treatment (saline, which is salt water). You wouldn't know which one you are getting, and neither would your doctors initially. You would have several assessments before, during, and after the infusion.

The main part of the study involves tracking your headaches in the weeks following the infusion. You would likely be asked to keep a diary or record to note down how often your headaches occur and how severe they are. You would also have check-ups, potentially including blood tests and questionnaires, to monitor your health, headache frequency, and how you're feeling overall, including your mood. The study will track your progress over several weeks, looking at how you respond at different time points after the infusion. The total duration of your active participation will involve these checks and follow-ups over a period of about three months.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit if the ketamine and magnesium infusion helps to reduce your cluster headache frequency, but there's no guarantee it will work for everyone, or at all. There's also a chance you might receive the dummy treatment, which won't directly treat your headaches. Potential risks could include side effects from the medications, which the medical team will monitor closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of headache is this study for?

This study is for people who have 'chronic refractory cluster headache', which means severe, ongoing cluster headaches that haven't responded well to other treatments.

What is an 'infusion'?

An infusion is a drip, where medication is slowly given to you through a small tube usually placed in a vein in your arm.

Will I know if I'm getting the active treatment or a dummy treatment?

No, initially you won't know, and neither will the study doctors. This helps ensure the results are unbiased.

How long will I be involved in the study?

Your active involvement, including follow-up assessments, will likely last about three months after the initial infusion.

What if I decide I don't want to continue with the study?

You are free to leave the study at any time, for any reason, without it affecting your medical care.