Last reviewed · How we verify
NCT04032379
Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
trial testing Standard treatment in Benign Intracranial Hypertension in 300 participants. Currently enrolling.
31 May 2027
Quick facts
| Lead sponsor | Danish Headache Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 14 February 2018 |
| Primary completion | 31 May 2027 |
| Estimated completion | 31 May 2027 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Standard treatment
Conditions studied
- Benign Intracranial Hypertension — all drugs for Benign Intracranial Hypertension →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04032379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Danish Headache Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04032379 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danish Headache Center
- Last refreshed: 7 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04032379.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing