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NCT04032379

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Recruiting now Last updated 7 March 2023
What this trial tests

trial testing Standard treatment in Benign Intracranial Hypertension in 300 participants. Currently enrolling.

Timeline
14 February 2018
Primary endpoint
31 May 2027
31 May 2027

Quick facts

Lead sponsorDanish Headache Center
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment300
Start date14 February 2018
Primary completion31 May 2027
Estimated completion31 May 2027
Sites2 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Danish Headache Center — full company profile →

Who can join

18 and older, any sex, with Benign Intracranial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Are the ICHD-3 criteria for headache attributed to idiopathic intracranial hypertension valid? Headache phenotyping and field-testing in newly diagnosed idiopathic intracranial hypertension.
    Hansen NS, Korsbæk JJ, Yri HM, Jensen RH, et al · · 2024 · cited 7× · PMID 38663903 · DOI 10.1177/03331024241248210

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Other trials of Standard treatment

Trials testing the same drug.

Other Danish Headache Center trials

Trials by the same sponsor.

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