NCT04032379

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2018May 2027

Study Start

First participant enrolled

February 14, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

9.3 years

First QC Date

July 12, 2019

Last Update Submit

March 6, 2023

Conditions

Benign Intracranial Hypertension

Outcome Measures

Primary Outcomes (6)

  • Biomarkers of IIH (diagnostic and prognostic)

    Analyses of CSF and blood for protein-markers (method: Proteomics)

    2 years

  • Visual status at conclusion of study

    Assessment of visual fields

    2 years

  • Visual status at conclusion of study

    Assessment of OCT

    2 years

  • Visual status at conclusion of study

    Assessment of visual acuity

    2 years

  • Headache status at conclusion of study

    Prevalence of chronic headache (\>=15 headache days per month)

    2 years

  • Biomarkers of IIH (diagnostic and prognostic)

    Analyses of CSF and blood for markers of metabolism (method: Metabolomics)

    2 years

Secondary Outcomes (8)

  • Baseline characteristics related to poor outcome

    1 year

  • Results of neuropsychological evaluations

    1 year

  • Treatment and follow-up

    3 years

  • Baseline characteristics related to IIH diagnosis

    2 years

  • Weight change in a standard care program

    2 years

  • +3 more secondary outcomes

Study Arms (3)

Certain IIH or IIH-WOP

According to revised diagnostic criteria, Friedmann, 2013.

Other: Standard treatment

Suspected IIH

IIH is suspected, does not fulfill diagnostic criteria.

Other: Standard treatment

IIH ruled out

Patients in whom another diagnosis is made.

Other: Standard treatment

Interventions

Standard treatmentOTHER

No intervention, some patients have additional neuro-psychological testing.

Certain IIH or IIH-WOPIIH ruled outSuspected IIH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All admitted or out-patient referrals where IIH is suspected. Patients will be identified and included consecutively once there is a clinical suspicion of IIH, if they wish to participate. Most often IIH will be suspected in a typical patient (female, child-bearing age, overweight) with either bilateral papiledema and normal neuro-imaging, high ICP by lumbar puncture or a new headache with associated visual disturbances or pulsatile tinnitus. All hospitals in the Capital Region of Denmark and the Southern Region of Denmark can participate and refer patients.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup

Copenhagen, Glostrup, 2600, Denmark

RECRUITING

Odense University Hospital, Department of Neurology

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Publications (10)

  • Durcan FJ, Corbett JJ, Wall M. The incidence of pseudotumor cerebri. Population studies in Iowa and Louisiana. Arch Neurol. 1988 Aug;45(8):875-7. doi: 10.1001/archneur.1988.00520320065016.

    PMID: 3395261BACKGROUND

  • Wall M, Kupersmith MJ, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, McDermott MP; NORDIC Idiopathic Intracranial Hypertension Study Group. The idiopathic intracranial hypertension treatment trial: clinical profile at baseline. JAMA Neurol. 2014 Jun;71(6):693-701. doi: 10.1001/jamaneurol.2014.133.

    PMID: 24756302BACKGROUND

  • Yri HM, Jensen RH. Idiopathic intracranial hypertension: Clinical nosography and field-testing of the ICHD diagnostic criteria. A case-control study. Cephalalgia. 2015 Jun;35(7):553-62. doi: 10.1177/0333102414550109. Epub 2014 Sep 16.

    PMID: 25228684BACKGROUND

  • Yri HM, Ronnback C, Wegener M, Hamann S, Jensen RH. The course of headache in idiopathic intracranial hypertension: a 12-month prospective follow-up study. Eur J Neurol. 2014 Dec;21(12):1458-64. doi: 10.1111/ene.12512. Epub 2014 Jul 29.

    PMID: 25070715BACKGROUND

  • Yri HM, Fagerlund B, Forchhammer HB, Jensen RH. Cognitive function in idiopathic intracranial hypertension: a prospective case-control study. BMJ Open. 2014 Apr 8;4(4):e004376. doi: 10.1136/bmjopen-2013-004376.

    PMID: 24713214BACKGROUND

  • Digre KB, Nakamoto BK, Warner JE, Langeberg WJ, Baggaley SK, Katz BJ. A comparison of idiopathic intracranial hypertension with and without papilledema. Headache. 2009 Feb;49(2):185-93. doi: 10.1111/j.1526-4610.2008.01324.x.

    PMID: 19222592BACKGROUND

  • Peng KP, Fuh JL, Wang SJ. High-pressure headaches: idiopathic intracranial hypertension and its mimics. Nat Rev Neurol. 2012 Dec;8(12):700-10. doi: 10.1038/nrneurol.2012.223. Epub 2012 Nov 20.

    PMID: 23165338BACKGROUND

  • Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

    PMID: 23771276BACKGROUND

  • Nielsen HH, Beck HC, Kristensen LP, Burton M, Csepany T, Simo M, Dioszeghy P, Sejbaek T, Grebing M, Heegaard NH, Illes Z. The Urine Proteome Profile Is Different in Neuromyelitis Optica Compared to Multiple Sclerosis: A Clinical Proteome Study. PLoS One. 2015 Oct 13;10(10):e0139659. doi: 10.1371/journal.pone.0139659. eCollection 2015.

    PMID: 26460890BACKGROUND

  • Hansen NS, Korsbaek JJ, Yri HM, Jensen RH, Beier D. Are the ICHD-3 criteria for headache attributed to idiopathic intracranial hypertension valid? Headache phenotyping and field-testing in newly diagnosed idiopathic intracranial hypertension. Cephalalgia. 2024 Apr;44(4):3331024241248210. doi: 10.1177/03331024241248210.

    PMID: 38663903DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Serum Cerebrospinalfluid (supernatant)

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial HypertensionBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rigmor Jensen, M.D., Dr.Med.

    The Danish Headache Center, Rigshospitalet-Glostrup

    STUDY DIRECTOR

  • Dagmar Beier, M.D., Ph.D.

    Odense University Hospital

    STUDY DIRECTOR

Central Study Contacts

Johanne Severinsen, M.D.

CONTACT

004538633553johanne.juhl.severinsen@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant, M.D.

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 25, 2019

Study Start

February 14, 2018

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)