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New treatment option for Idiopathic Intracranial Hypertension (IIH)
Official title Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
ClinicalTrials.gov ID: NCT06945848
What this study is testing
What is Acetazolamide?
Acetazolamide is an investigational medicine, being studied as a potential treatment for idiopathic intracranial hypertension (iih).
Also referred to as Weight loss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and/or tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy). The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years old at inclusion.
- Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ...
- Patient with elevated intracranial pressure defined as \> 25 cm H20 or 18 mmHg
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
You likely can't join if
- Patients receiving topiramate in the previous month
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug (other than ACZ), substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of...
- History of intracranial venous thrombosis or intracranial neoplasia
- Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected...
- Optic nerve atrophy
See the full eligibility criteria
- Subject is ≥ 18 years old at inclusion.
- Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year
- Patient with elevated intracranial pressure defined as \> 25 cm H20 or 18 mmHg
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
- Patient having received information about data collection and having signed and dated an Informed Consent Form
- people must be able to attend all scheduled visits and to comply with all trial procedures
- people must be covered by public health insurance
- Patients receiving topiramate in the previous month
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug (other than ACZ), substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
- History of intracranial venous thrombosis or intracranial neoplasia
- Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology...
- Optic nerve atrophy
- Amblyopia
- Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss
- Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
- Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
- Life expectancy under 6 months
- Patients with renal failure (creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min, except if patient is already on hemodialysis)
- History of previously implanted intra-cranial sinus stent
- Previous gastric bypass surgery AAP-DGOS PHRC-N 22\_0175 CHU DE MONTPELLIER Pr Costalat Vincent/Pr Ducros Anne Version n°2.2 date 25/03/2025 Page 28 sur 63
- Contra-indication to general anesthesia
- Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
- History of chronic obstructive pulmonary disease or other severe respiratory disease
- History of deep vein thrombosis or pulmonary embolism
- History of atrial fibrillation or other risks of stroke
- Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery...
- Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
- Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Reims, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Reims, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.