Study on Amlodipine for Treating Reversible Cerebral Vasoconstriction Syndrome in Patients Without Brain Lesions or Hemorrhage

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What is this study about?

This clinical trial is focused on studying a condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS). This condition involves the temporary narrowing of blood vessels in the brain, which can lead to severe headaches. The study will explore the use of a medication called Amlodipine, which is a type of drug known as a calcium channel blocker. This medication is commonly used to treat high blood pressure by helping to relax blood vessels.

The purpose of the study is to determine if adding Amlodipine to the standard care for patients with RCVS can help reduce the frequency of recurring headache attacks. Participants in the study will be randomly assigned to receive either Amlodipine or a placebo, and neither the participants nor the researchers will know which treatment is being given. This is known as a double-blind study. The study will last for a period of up to 12 weeks, during which participants will take the medication orally in the form of a tablet.

Throughout the study, the main focus will be on observing how often headaches occur. Additionally, researchers will monitor for any changes in the brain’s blood vessels using imaging techniques like CT (computed tomography) or MRI (magnetic resonance imaging). The study will also look for any potential complications, such as strokes or other issues, and assess the intensity of headache attacks. The goal is to gather information that could lead to better treatment options for those affected by RCVS.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide consent to participate.

You will be assessed to ensure you meet the criteria for participation, such as being 18 years or older and having specific headache symptoms.

2 initial assessment

An initial assessment will be conducted, which may include imaging tests to confirm the presence of cerebral vasoconstriction and the absence of certain conditions like hemorrhage.

This assessment helps to establish a baseline for your condition before starting the trial medication.

3 medication administration

You will be randomly assigned to receive either the trial medication, amlodipine, or a placebo. Amlodipine is a medication taken by mouth.

The dosage and frequency of the medication will be determined by the study protocol, and you will be instructed on how to take it.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your condition and any changes in your symptoms.

During these visits, you may undergo additional imaging tests to assess the effects of the medication on your condition.

5 reporting symptoms

You will be asked to keep a record of your headache symptoms, including their frequency and intensity.

This information is crucial for evaluating the effectiveness of the treatment.

6 final assessment

At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

This may include imaging tests and a review of your symptom records.

Who Can Join the Study?

Must be 18 years or older at the start of the study.
Experience a thunderclap headache (a headache that reaches its worst pain within one minute) or have severe recurring headaches.
Show cerebral vasoconstriction (narrowing of blood vessels in the brain) on imaging tests in at least two different arteries, or in one artery along with the typical symptoms of a thunderclap headache.
No signs of acute or subacute infarction (recent or developing stroke), bleeding, or findings that suggest posterior reversible encephalopathy syndrome (a condition that affects the brain) on CT or MRI scans.
No presence of aneurysmal subarachnoid hemorrhage (bleeding in the space around the brain due to a burst blood vessel).

Who Cannot Join the Study?

Patients with reversible cerebral vasoconstriction syndrome cannot participate if they have parenchymal lesions (areas of damage in the brain tissue) or subarachnoid hemorrhage (bleeding in the space around the brain) visible on CT/MRI scans.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hqhqondg Utbjwsfbim Cfonkoq Hycmkgpq	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.02.2025

Trial locations

Investigated drugs:

Amlodipine

Calcium Channel Blocker is a type of medication used in this clinical trial. It works by relaxing the blood vessels, which can help to improve blood flow and reduce the frequency of headaches. In this study, the calcium channel blocker is being tested to see if it can help people with a condition called reversible cerebral vasoconstriction syndrome. This condition can cause severe headaches, and the medication is being added to the usual care to see if it can make a difference in reducing these headache attacks.

Reversible cerebral vasoconstriction syndrome – This condition involves a temporary narrowing of the blood vessels in the brain. It is characterized by sudden, severe headaches, often described as thunderclap headaches. The syndrome can lead to other symptoms such as nausea, vomiting, and visual disturbances. The narrowing of the blood vessels can cause changes in blood flow, potentially leading to complications if not resolved. Over time, the blood vessels typically return to their normal state, and symptoms improve. The condition is often self-limiting, with symptoms resolving as the blood vessels relax and widen again.

Trial ID:

2023-504547-14-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Amlodipine for Treating Reversible Cerebral Vasoconstriction Syndrome in Patients Without Brain Lesions or Hemorrhage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?