CompletedNot SpecifiedInterventional

IIH Pressure - a new treatment for raised brain pressure in Idiopathic Intracranial Hypertension

Idiopathic intracranial hypertension (IIH) is a condition where fluid builds up around the brain without a clear cause. This extra pressure can trigger painful, daily headaches and squash the nerves in the eyes, which can damage eyesight. Currently, effective treatments are limited. This trial looks at whether a medicine called exenatide—originally used for diabetes and weight management—can help reduce fluid pressure in the brain. Researchers also want to test five other commonly used tablets. Women aged 18 to 60 with active IIH can take part. Participants have a small, temporary sensor fitted under the scalp to read brain pressure easily. In the first phase, they receive either exenatide or a dummy injection (placebo) for 12 weeks. In the second phase, they test short courses of other medications. The goal is to discover new, effective treatments to protect sight and relieve headaches.

At a glance

Status

Completed

Phase

Not Specified

Sponsor

University of Birmingham

Enrolment target

Start

31 Jul 2017

Estimated completion

31 Jul 2018

Idiopathic intracranial hypertension

What is this study about?

Idiopathic intracranial hypertension (IIH) is a condition where pressure builds up inside the skull. The word "idiopathic" means doctors do not yet know the exact underlying cause. When fluid builds up around the brain, it puts pressure on the optic nerve, which carries signals from your eye to your brain. This can lead to persistent, throbbing headaches and can cause serious, permanent changes to your eyesight or even blindness.

At present, there are very few treatments that directly lower brain pressure. Weight loss can be very effective, but losing weight takes time, and existing medications often cause difficult side effects or do not work well enough. Scientists have discovered that a natural gut hormone called GLP-1 helps regulate fluids in the kidneys. Early lab research suggests it may also reduce the amount of fluid produced inside the brain, which could help lower brain pressure.

This trial investigates a GLP-1 medication called exenatide, which is already used to treat type 2 diabetes. By fitting a tiny wireless sensor under the scalp, doctors can measure brain pressure painlessly without the need for repeated spinal taps (lumbar punctures). The study aims to see if exenatide, alongside other standard tablets, can safely reduce brain pressure and improve quality of life for people living with IIH.

Key takeaways

The trial tests if exenatide, a diabetes drug, can lower fluid pressure in the brain for people with IIH.
It is open to women aged 18 to 60 with active IIH and swelling of the eye nerves.
Participants receive a tiny wireless sensor under the scalp to measure brain pressure painlessly.
The study compares twice-daily injections against a placebo over 12 weeks, followed by short tests of other medicines.
Joining is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is open to women aged between 18 and 60 who have a confirmed diagnosis of active IIH. Active disease means your brain pressure is significantly raised (higher than 25 cm CSF) and an eye doctor can see swelling at the back of your eyes, known as papilloedema.

You cannot take part if you are pregnant, planning to become pregnant, or already have a device fitted to drain brain fluid, such as a shunt or stent. You also cannot join if you currently use GLP-1 medications, have certain hormone conditions like Cushing's or Addison's disease, or have blood clots in the veins of the brain.

If you take regular water tablets or specific pressure medicines like acetazolamide or topiramate, your doctor may check whether it is safe for you to stop taking them for one month before starting the trial. You must also be well enough to undergo a minor procedure under anaesthetic.

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.

I am a woman aged between 18 and 60.
I have a confirmed diagnosis of active IIH.
My eye doctor has confirmed swelling at the back of my eyes (papilloedema).
I do not have a brain shunt, stent, or past eye-nerve surgery.
I am not pregnant or trying to become pregnant.

Answer every question to see your result.

What does participation involve?

Taking part in the study involves two main parts over several months. First, a specialist surgeon will fit a tiny wireless pressure sensor just beneath your scalp during a short procedure under anaesthetic. This sensor allows doctors to measure your brain pressure from outside your head without needles.

In Part 1, you will be randomly placed into one of two groups. One group receives exenatide, and the other receives a dummy injection (placebo). You will give yourself these small skin injections twice daily for 12 weeks. You will visit the clinic at 2 weeks and 12 weeks for painless pressure readings, blood tests, headache diaries, and simple memory checks.

In Part 2, you will test one of five common tablets for two weeks at a time, with a one-week rest period between medicines. In total, the study involves regular check-ups over around 4 to 6 months, after which your medical team will discuss your progress and arrange sensor care or removal.

Potential risks and benefits

Taking part offers the benefit of closer medical monitoring and painless brain pressure tracking using the wireless sensor. The treatments may also help relieve your headaches and lower pressure on your eyes. However, there are risks to consider. Fitting the sensor is a minor surgical procedure and carries small risks of bleeding, infection, seizures, or anaesthetic reactions. Rarely, a sensor might stop working and need to be removed. Exenatide can cause side effects like nausea, and in rare cases, inflammation of the pancreas (pancreatitis). Taking part is completely voluntary, and you are free to stop at any time without it affecting your standard NHS care.

Locations (6)

Queen Elizabeth Hospital Birmingham
Approximate
Birmingham, England
Sandwell General Hospital
Approximate
West Bromwich, England
Gloucester Royal Hospital
City only
Gloucester, England
Leicester General Hospital
Approximate
Leicester, England
Royal Hallamshire Hospital
Approximate
Sheffield, England
University Hospital Coventry and Warwickshire
Unverified
Coventry, England

Common questions

Will taking part in this study cost me anything?

No. The study procedures, medications, and check-ups are free of charge through the NHS and trial funders.

What is a placebo and why is it used?

A placebo is a dummy treatment that looks identical to the real medicine but contains no active drug. It helps researchers prove whether any improvements are truly caused by the medication.

How does the pressure sensor work?

The sensor is a tiny device placed under the scalp. When a nurse or doctor holds a small reader over your head, it wirelessly records your brain pressure without causing any pain.

Can I keep taking my usual painkillers?

Your study team will give you clear advice on which pain relief medications you can safely take for headaches during the trial.

Can I leave the trial if I change my mind?

Yes. You have the right to withdraw from the study at any time without giving a reason, and your regular medical care will continue as normal.

How to find out more

James Mitchell

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.