Identifying biomarkers for idiopathic intracranial hypertension
Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
This study is trying to find specific markers in the body that can help diagnose and predict outcomes for women of childbearing age who might have idiopathic intracranial hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Headache Center Academic / other |
| Locations | 2 sites (Copenhagen, Glostrup and 1 other locations) |
| Trial ID | NCT04032379 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify diagnostic and prognostic biomarkers for idiopathic intracranial hypertension (IIH), a condition primarily affecting overweight females of childbearing age. It involves a multicenter, prospective cohort design where patients suspected of having IIH will be included based on specific criteria. Participants will undergo a series of evaluations, including medical history, neurological and ophthalmological examinations, neuro-imaging, and collection of blood and cerebrospinal fluid samples. The study will create a clinical database to track patient characteristics and outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are suspected of having idiopathic intracranial hypertension.
Not a fit: Patients who are unable to provide informed consent or have conditions that preclude participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic capabilities for patients with idiopathic intracranial hypertension.
How similar studies have performed: While there is ongoing research in this area, the specific approach of identifying biomarkers for IIH is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Copenhagen, Glostrup and 1 other locations
- The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup — Copenhagen, Glostrup, Denmark (Recruiting)
- Odense University Hospital, Department of Neurology — Odense, Region Syddanmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Johanne Severinsen, M.D.
- Email: johanne.juhl.severinsen@regionh.dk
- Phone: 004538633553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.