NCT06945848

Brief Summary

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. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical care + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
45mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

April 3, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2030

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

April 3, 2025

Last Update Submit

March 5, 2026

Conditions

Idiopathic Intracranial Hypertension (IIH)

Keywords

Intracranial hypertensionPapillary edemaStentingTransverse sinus veinChronic headacheTinnitus

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with normalization of intra-cranial pressure

    Rate of patients with normalization of intra-cranial pressure (defined as ≤ 25 cm H20 or 18 mmHg)

    3 months

Secondary Outcomes (13)

  • Discontinuation of Acetazolamide

    1 month

  • Discontinuation of Acetazolamide

    3 months

  • Headache

    3 and 12 months

  • Monthly headache days

    3 and 12 months

  • Tinnitus

    3 and 12 months

  • +8 more secondary outcomes

Study Arms (2)

Acetazolamide

ACTIVE COMPARATOR

Acetazolamide and recommended weight loss

Drug: Acetazolamide

Experimental (stenting, neuro-radiological intervention)

EXPERIMENTAL

Stenting of the transverse sinus vein

Device: Stent (Tentos 4F or Precise ProRX)

Interventions

AcetazolamideDRUG

Acetazolamide will be maintained and weight loss will be recommended

Also known as: Weight loss
Acetazolamide
Stent (Tentos 4F or Precise ProRX)DEVICE

Transverse venous sinus will be stented by neuroradiological intervention

Experimental (stenting, neuro-radiological intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Subjects must be able to attend all scheduled visits and to comply with all trial procedures
  • Subjects must be covered by public health insurance

You may not qualify 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 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 and Mean Deficit of visual field superior to -10 dB
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Montpellier Hôpital Gui de Chauliac

Montpellier, 34295, France

RECRUITING

CHU de Reims

Reims, 51092, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pseudotumor CerebriIntracranial HypertensionHeadache DisordersTinnitus

Interventions

AcetazolamideStents

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Vincent COSTALAT, MD, PhD

    University hospital of Montpellier, FRANCE

    STUDY DIRECTOR

Central Study Contacts

Vincent COSTALAT, MD, PhD

CONTACT

+33 467 337 532v-costalat@chu-montpellier.fr

Fédérico CAGNAZZO, MD, PhD

CONTACT

+33 467 337 532f-cagnazzo@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 25, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

January 5, 2029

Study Completion (Estimated)

January 5, 2030

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)