NCT04032379 Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
| NCT ID | NCT04032379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Headache Center |
| Condition | Benign Intracranial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-02-14 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2018-02-14 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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).
Contact & Investigator
Rigmor Jensen, M.D., Dr.Med.
STUDY DIRECTOR
The Danish Headache Center, Rigshospitalet-Glostrup
Frequently Asked Questions
Who can join the NCT04032379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Benign Intracranial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04032379 currently recruiting?
Yes, NCT04032379 is actively recruiting participants. Contact the research team at johanne.juhl.severinsen@regionh.dk for enrollment information.
Where is the NCT04032379 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT04032379 clinical trial?
NCT04032379 is sponsored by Danish Headache Center. The principal investigator is Rigmor Jensen, M.D., Dr.Med. at The Danish Headache Center, Rigshospitalet-Glostrup. The trial plans to enroll 300 participants.