Idiopathic Intracranial Hypertension (IIH)

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Review clinical trials related to Idiopathic Intracranial Hypertension (IIH). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

The goal of this clinical trial is to learn if eptinezumab can reduce headache frequency and headache-related disability in adults with idiopathic intracranial hypertension (IIH) and chronic headache. It will also evaluate the safety and tolerability of eptinezumab in this patient population. The main questions it aims to answer are: * Does eptinezumab reduce the number of monthly moderate-to-severe headache days compared with placebo? * Does eptinezumab improve headache-related disability and patient-reported outcomes? * What adverse events occur during treatment with eptinezumab? Researchers will compare eptinezumab to placebo to determine whether eptinezumab is effective in the prevention of chronic headache in patients with IIH. Participants will: * Receive eptinezumab or placebo according to random assignment. * Attend scheduled study visits and clinical assessments. * Complete headache diaries and questionnaires during the study period. * Undergo study-related examinations and collection of biological samples, including blood samples.

Participants needed: 96
Trial details
Phase: Phase 3Age: 18-55Biological sex: FemaleType: InterventionalSponsor: Rigmor Højland JensenUpdated: Jun 12, 2026
Eligibility criteria

Female, aged 18 to 55 years [+5]

Non-compliance with headache diary completion during screening, defined as less... [+4]

Status: Not yet recruiting

Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent

The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus stenoses associated with IIH.

Participants needed: 99
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Acandis GmbHUpdated: May 1, 2026
Eligibility criteria

Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modifie... [+6]

Status: Recruiting

BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment

1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments. 2. To establish the BMI at which this disease occurs. 3. To establish how much the BMI must be reduced to cure this disease. 4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of ValenciaUpdated: Apr 22, 2026Locations: 1
Eligibility criteria

Adults aged 18 years and older at the time of enrollment. There is no upper age... [+2]

A diagnosis other than IIH, specifically: tension-type headache, Chiari I malfor... [+1]

Status: Recruiting

Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

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.

Participants needed: 114
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, MontpellierUpdated: Mar 6, 2026Locations: 3
Eligibility criteria

Subject is ≥ 18 years old at inclusion. [+7]

Patients receiving topiramate in the previous month [+24]

Status: Not yet recruiting

Tirzepatide in Idiopathic Intracranial Hypertension Trial

This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Nov 14, 2025Locations: 1
Eligibility criteria

headaches, tinnitus, visual obscurations, papilledema; [+9]

Previous bariatric surgery [+17]

Status: Recruiting

Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase

This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. 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 car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Participants needed: 114
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, MontpellierUpdated: Oct 3, 2025Locations: 3
Eligibility criteria

Subject is ≥ 18 years old at inclusion. [+8]

Subject previously treated with acetazolamide for IIH [+26]

Status: Recruiting

Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.

Participants needed: 30
Trial details
Age: 18-55Biological sex: AllType: ObservationalSponsor: Thomas Jefferson UniversityUpdated: May 2, 2025Locations: 1
Eligibility criteria

History of head trauma and shunting or leak repair [+2]

Status: Not yet recruiting

Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension

This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.

Participants needed: 40
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Feb 18, 2025Locations: 1
Eligibility criteria

40 Patients of idiopathic intracranial hypertension subjected to Dural venous si... [+6]

Age less than or equal to 18 years. [+4]