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Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining…

ClinicalTrials.gov IDNCT04032379
PhaseNot Applicable
Enrollment300
SponsorDanish Headache Center
Age18 Years
SexALL
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Conditions studied

Benign Intracranial Hypertension

About this study

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome. This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid). The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: 1. Able to and willing to provide informed consent 2. More than 18 years of age 3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist) Exclusion Criteria: 1.) Unable to consent (e.g. language, mental retardation).

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.