Phase 3 Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a condition called Idiopathic Intracranial Hypertension (IIH) — a condition involving raised pressure in the brain without a known cause — for more than 2 months, confirmed using standard diagnostic criteria
• People whose spinal fluid pressure, measured by a lumbar puncture (a procedure where a needle is inserted into the lower back), was 250 mmH₂O or higher within the 6 weeks before joining the trial
• People whose spinal fluid has been tested and shown to have a normal composition
• People whose brain scans (CT or MRI) show a normal brain with no swelling, growths, or structural problems, and no signs of inflammation around the brain's lining
• People whose brain scans show a specific type of narrowing in a brain vein (called venous sinus stenosis), where the narrowing is 50% or more and there is a measurable pressure difference across the narrowed area, confirmed by a specialised blood vessel scan (called a DSA)
• People (or their family members, where appropriate) who have signed a written consent form agreeing to take part
• People where at least one eye shows swelling of the optic nerve at the back of the eye (called papilledema)
• People where at least one eye shows a specific level of vision loss on a standard visual field test, with results that can be reliably repeated
• People whose vision is above a certain level (better than 20/200, or at least 39 letters on a standard eye chart)

Who may not be able to join:

• People who have previously had surgery for IIH, including procedures such as optic nerve sheath fenestration, a brain fluid shunt, skull decompression surgery, or a vein stenting procedure
• People experiencing rapidly worsening vision loss that requires urgent surgery
• People whose vision loss is caused by something other than IIH, such as retinal conditions, cataracts, or other eye or nerve problems
• People who need to take diuretics (water tablets), steroids, or other medications to lower brain pressure for a reason other than IIH
• People whose specialised brain vein scan (DSA) shows widespread narrowing throughout the venous sinuses, or narrowing in smaller or deeper veins
• People with a history of serious thyroid disease or an allergy to iodine
• People who are pregnant or currently breastfeeding
• People with severe heart, lung, liver, or kidney failure
• People with a known condition — inherited or acquired — that affects bleeding or blood clotting, including abnormal platelet counts or clotting test results
• People who have had major surgery, a serious injury, or a traumatic brain injury within the past 14 days
• People with a history of bleeding in the brain, abnormal brain blood vessel connections (arteriovenous malformation), a brain aneurysm, or a brain tumour
• People with another serious life-threatening illness (such as advanced cancer) that may affect their ability to complete the trial, or who have circumstances — such as substance dependence or lack of support — that may make follow-up difficult
• People whose raised brain pressure is caused by another identified medical condition rather than IIH
• People whose eye pressure is currently above 28 mmHg, or has previously been above 30 mmHg
• People with a significant prescription strength in their glasses (beyond a certain range for short-sightedness or long-sightedness, or significant astigmatism), with some exceptions for those within a slightly broader range who meet additional specific eye health conditions and who wear contact lenses for all vision field tests (confirm with trial site)
• People with large drusen (calcium deposits) on the optic disc visible on examination or known from medical history, unless the investigator determines that small numbers are unrelated to vision loss

Important: Always verify eligibility with the trial site directly before applying.