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NCT04032379Recruiting

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Source: ClinicalTrials.gov · Last updated 7 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
12 Jul 2019
Start date
14 Feb 2018
Primary completion date
31 May 2027
Lead sponsor
Danish Headache Center
NCT number
NCT04032379

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 14 Feb 2018 to the primary completion date, 31 May 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 1.) Unable to consent (e.g. language, mental retardation).

Who the study is looking for

  • Able to and willing to provide informed consent
  • More than 18 years of age
  • Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
Odense University Hospital - Department of Neurology
Coordinator of this site? Confirm its status
OdenseDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.