AuthorisedTherapeutic use (Phase IV)Interventional

Calcium Channel blocker in treatment of reversible cerebral vasoconstriction syndrome: a double-blind, randomized, placebo-controlled trial.

This research is looking into a medicine called amlodipine to see if it can help people who have a condition called Reversible Cerebral Vasoconstriction Syndrome, or RCVS. This condition causes temporary narrowing of blood vessels in the brain, often leading to severe headaches. The study aims to find out if amlodipine can make headaches happen less often and prevent other more serious problems, such as strokes, that can sometimes occur with RCVS. This is a very important type of study where some people will receive amlodipine and others will receive a dummy pill (placebo) to fairly compare the effects. Researchers will also check if the narrowing of brain vessels improves. It’s for adults aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS Helsinki University Hospital

Enrolment target

100

Start

05 May 2025

Reversible cerebral vasoconstriction syndrome

What is this study about?

This study is investigating a condition called Reversible Cerebral Vasoconstriction Syndrome, often shortened to RCVS. If you have RCVS, the blood vessels in your brain can temporarily narrow, which often causes sudden and very severe headaches, like a 'thunderclap' headache. While these blood vessels usually return to normal on their own, doctors are looking for ways to treat the condition and prevent problems.

Researchers want to see if a commonly used medicine called amlodipine, which is usually prescribed for high blood pressure, can help people with RCVS. They think it might help by relaxing the blood vessels. The main goal of the study is to find out if taking amlodipine can reduce how often these severe headaches come back. They will also look at how strong the headaches are when they do happen.

Beyond headaches, the study will also check to see if amlodipine helps prevent any serious issues that can sometimes happen with RCVS, like a stroke or other brain complications. They'll use scans like CT or MRI to see if the blood vessels in the brain go back to their normal size, which would mean the treatment is working. This is a "Phase IV" study, which means the medicine is already approved for other uses, and now doctors want to learn more about its effects specifically for RCVS.

Key takeaways

The study explores if amlodipine can help people with Reversible Cerebral Vasoconstriction Syndrome (RCVS).
It aims to reduce the frequency and intensity of severe headaches caused by RCVS.
Researchers will also check if this medicine can prevent serious complications like strokes.
Participation involves receiving either amlodipine or a dummy pill and having follow-up brain scans.
This is a late-stage study, meaning amlodipine is already a known medicine for other conditions.
The study is for adults aged 18 and older.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can potentially take part.

Both men and women are welcome to participate in this research. The study aims to include a wide range of people to understand how the treatment might work across different individuals with RCVS.

Specific medical details about your RCVS and any other health conditions you might have will need to be checked by the study doctors to make sure the trial is safe and suitable for you.

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.

Are you 18 years old or older?
Have you been diagnosed with Reversible Cerebral Vasoconstriction Syndrome (RCVS)?
Are you willing to potentially receive either the study drug or a dummy pill?
Are you able to attend regular clinic visits and have brain scans (like CT or MRI)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the study medicine (amlodipine) or a dummy pill (placebo). Neither you nor your study doctor will know which one you are taking. You will have regular visits to the clinic where doctors will assess your headaches, including how often they happen and how severe they are. You will also have follow-up brain scans, such as CT or MRI, to check on your blood vessels and ensure there are no complications. The team will explain the full schedule of visits and assessments, which will involve regular check-ups and potentially blood tests. The total duration of your participation will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in this study might offer a potential benefit if amlodipine helps reduce your headaches or prevents complications of RCVS, but there's no guarantee. You might also gain satisfaction from contributing to medical knowledge that could help future patients. Potential risks could include side effects from amlodipine, although it's a widely used medicine and generally well-tolerated. Common side effects can include headache, swelling in the ankles, or flushing. There's also a chance you might receive the dummy pill, meaning you won't get any active treatment from the study medicine. You are always in control and 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
Finland

Common questions

What is Reversible Cerebral Vasoconstriction Syndrome (RCVS)?

RCVS is a condition where the blood vessels in your brain temporarily narrow, often causing very sudden and severe headaches. These vessels usually return to normal on their own.

What is amlodipine?

Amlodipine is a medicine commonly used to treat high blood pressure, but in this study, doctors are investigating if it can also help with RCVS.

What does 'double-blind, placebo-controlled' mean?

It means some people get the study medicine, and others get a dummy pill (placebo). Neither you nor your doctor will know which you are receiving, to ensure the results are fair.

Will I have to have brain scans?

Yes, part of the study involves having brain scans like CT or MRI to check the blood vessels and look for any changes.

Who can join this study?

Adults aged 18 and over, both men and women, who have been diagnosed with RCVS may be able to join.