Intracranial Hypertension Clinical Trials 2023

What are Intracranial Hypertension Clinical Trials?

Intracranial hypertension (IH) is the increase of pressure around the brain and is classified into three types:

• Acute IH: Pressure build-up around the brain caused by stroke, severe head injury, or brain abscess.
• Chronic IH: A long-term pressure build-up caused by a brain tumor, a chronic subdural hematoma, infection, hydrocephalus, abnormal blood vessels, or venous sinus thrombosis.

When the underlying cause of chronic IH is unknown, it is called idiopathic IH and is seen mainly in women ages 20 – 30. Possible reasons for IIH include obesity, hormonal disbalance, reaction to medicine, chronic kidney disease, and lupus.

Symptoms of IH include a constant throbbing headache that can vary in intensity, temporary loss of eyesight, tinnitus, nausea, lethargy, and irritability. If left untreated, IH can cause permanent loss of vision.

Why Is Intracranial Hypertension Being Studied In Clinical Trials?

Estimates suggest 2 in 100,000 people have idiopathic intracranial hypertension (IIH), with women being 20 times more likely to be affected than men. The reasons for this and the cause are still unknown.

Clinical trials can offer insight into the internal mechanism leading to excess pressure around the brain. Researchers have proposed a number of theories, such as excess cerebrospinal fluid, increased blood volume, or obstructions in the veins that drain the blood from around the brain. However, further investigation is necessary to understand the cause and determine the risk factors, which can lead to a cure for this condition.

How Does Intracranial Hypertension Treatment Work?

Intracranial hypertension (IH) is diagnosed after several examinations, including, but not limited to, CT scans, MRIs, MR venograms, contrast-enhanced MRV, and lumbar punctures.

Lumbar punctures are often done to reduce the fluid around the brain and provide immediate pressure relief. While it can be done repeatedly, it can lead to infection and is uncomfortable for patients.

As there is no definite cure for IH, management options focus on decreasing the symptoms, particularly vision loss. Medications such as painkillers, acetazolamide (to decrease the amount of cerebrospinal fluid the body makes), and furosemide (a diuretic to decrease the fluid in the body) are prescribed.

Two surgical options are currently available to reduce the pressure, optic nerve sheath decompression and shunting. Though riskier, these are the best options for patients not responding to medications with severe symptoms.

What Are Some of the Breakthrough Clinical Trials Involving Intracranial Hypertension?

2016: This trial was the first to study the effectiveness and safety of AZD4017, a 11β-HSD1 inhibitor, to treat intracranial hypertension by reducing the pressure. Thirty-one female patients aged 18 – 55 were divided into a treatment and placebo group. Then cerebrospinal fluid (CSF) was measured over 12 weeks. Findings showed a decrease in CSF.

2018: A clinical trial aimed to determine the primary clinical and lab factors of patients with untreated idiopathic intracranial hypertension (IIH). One of the most extensive studies done to collect data on IIH observed and tested 165 patients, and one of its findings showed IIH was mainly in obese young women.