Clinical Trial

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Recruiting
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Summary
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-07-23; most recent amendment 2023-03-06.
Trial Details
NCT Number NCT04032379
Lead Sponsor Danish Headache Center
Collaborators: Odense University Hospital
Conditions Benign Intracranial Hypertension
Enrollment 300 participants
Start Date 2018-02-14
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2023-03-07