Study on Ketamine and Magnesium Sulfate for Treating Chronic Cluster Headache in Patients Unresponsive to Standard Treatments

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What is this study about?

This clinical trial is focused on studying a severe type of headache known as chronic cluster headache, which is a condition that causes intense pain and is difficult to treat with standard medications. The study is exploring the use of two well-known medications, ketamine and magnesium sulfate, to see if they can help relieve this type of headache in patients who have not found relief with other treatments. The trial will compare the effects of a single infusion of these medications to a control group receiving hydroxyzine, which acts as an active placebo.

The purpose of the study is to evaluate the effectiveness of this treatment approach. Participants will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will monitor changes in the frequency and intensity of headache attacks over several weeks following the infusion. Participants will also be assessed for any side effects and their overall response to the treatment.

Throughout the study, researchers will collect data on how often and how severe the headaches are, as well as any changes in anxiety and depression levels. The study aims to provide insights into whether this combination of medications can offer a new option for those suffering from chronic cluster headaches who have not benefited from existing treatments.

1 initial visit

Upon joining the study, the first step involves an initial visit to the clinical trial site. During this visit, eligibility is confirmed based on specific criteria, such as age and diagnosis of chronic cluster headache.

A detailed explanation of the trial process is provided, and informed consent is obtained. This ensures understanding and agreement to participate in the study.

2 pre-treatment assessment

Before receiving any treatment, a pre-treatment assessment is conducted. This includes recording the frequency of headache crises over a 14-day period.

This assessment helps establish a baseline for comparing the effects of the treatment.

3 treatment administration

The treatment involves a single intravenous infusion of ketamine combined with magnesium sulfate. This is administered at the clinical trial site.

Some participants may receive hydroxyzine as an active placebo, which is a substance with no therapeutic effect used for comparison.

4 post-treatment monitoring

After the infusion, monitoring occurs to observe any changes in the frequency and intensity of headache crises.

This monitoring period includes several checkpoints: days 7-13, 14-20, 21-27, and 28-34 post-infusion.

5 follow-up assessments

Follow-up assessments are conducted to evaluate the overall response to the treatment. This includes measuring the frequency of headache crises and any changes in anxiety and depression levels.

Additional assessments may include evaluating the need for further treatment and any side effects experienced.

6 final evaluation

A final evaluation is conducted on day 90 to assess the long-term effects of the treatment.

This evaluation includes a comprehensive review of the patient’s condition and any changes in their headache patterns.

Who Can Join the Study?

Must be 18 years or older.
Must have a diagnosis of chronic cluster headache according to specific medical guidelines (ICHD-3 criteria).
Must experience at least 2 headache attacks per day on average during the 14 days before receiving the study treatment.
Must have tried and found three major treatments for cluster headaches (verapamil, lithium, and corticosteroids) to be ineffective, not tolerated, or unsuitable for use.
Must provide informed consent, meaning you agree to participate after understanding the study details.

Who Cannot Join the Study?

Patients who do not have refractory chronic cluster headache cannot participate. This means the study is only for those who have a specific type of headache that does not respond to usual treatments.
Patients who are not within the specified age range cannot participate. The study is for adults aged 18 to 65 years old.
Patients who are part of a vulnerable population cannot participate. This includes groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ctykawoj Bjrp Spudnp	Montpellier	France
Arljnndvhg Prsgzpty Heiwcixl Dw Mlkqlaqlx	Marseille	France
Iwzmjgrd dw Cgbqrcjreava Hkwkncmrkec Uqnyvrmdlwrwc dg Sqmci Eapknhm (kkeduuv	Saint Priest En Jarez	France
Hoiehzft Uapuexpvtrlory Snisgrnvui &bwpwzr Hqxhqfr dn Hhaoojlvqip	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.09.2021

Trial locations

Investigated drugs:

Ketamine is a medication that is often used for pain relief and as an anesthetic. In this trial, it is being tested to see if it can help reduce the pain from chronic cluster headaches, which are severe headaches that occur in cycles. Ketamine works by affecting certain chemicals in the brain to help decrease pain and discomfort.

Magnesium sulfate is a mineral that is sometimes used to treat low levels of magnesium in the blood. In this trial, it is being used alongside ketamine to see if it can enhance the pain-relieving effects for people suffering from chronic cluster headaches. Magnesium sulfate may help by relaxing blood vessels and reducing inflammation, which can contribute to headache relief.

Hydroxyzine is a medication that is commonly used to treat anxiety and tension. In this trial, it is used as a comparison treatment to see how effective the combination of ketamine and magnesium sulfate is. Hydroxyzine can help calm the nervous system, which might provide some relief from headache symptoms, but it is not the main focus of the study.

Investigated diseases:

Cluster headache

Refractory Chronic Cluster Headache – Refractory chronic cluster headache is a neurological disorder characterized by severe, recurring headaches that are resistant to standard treatments. These headaches typically occur in cyclical patterns or clusters, with each episode lasting from weeks to months, followed by periods of remission. The pain is usually unilateral, centered around one eye, and can be accompanied by symptoms such as tearing, nasal congestion, or drooping eyelids. The exact cause of cluster headaches is not well understood, but they are believed to involve abnormalities in the hypothalamus and disruptions in circadian rhythms. The condition is more common in men and often begins in adulthood. Over time, the frequency and intensity of the headache episodes can vary, making management challenging.

Trial ID:

2024-518943-38-00

Protocol code:

RBHP 2020 MOISSET

NCT ID:

NCT04814381

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ketamine and Magnesium Sulfate for Treating Chronic Cluster Headache in Patients Unresponsive to Standard Treatments

What is this study about?

Who Can Join the Study?

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