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Benign Intracranial HypertensionNCT04032379

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

An observational study of Benign Intracranial Hypertension, run by Danish Headache Center at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benign Intracranial Hypertension
What is being tested?
Standard treatment
How many people
300 participants
Where
2 sitesDenmark
Study dates
14 Feb 2018to 31 May 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Johanne Severinsen, M.D. contact

004538633553

johanne.juhl.severinsen@regionh.dk

Denmark2 sites, 2 recruiting

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

    Copenhagen, Glostrup, 2600

    Johanne Severinsen, M.D., johanne.juhl.severinsen@regionh.dk

    Recruiting

  • Odense University Hospital, Department of Neurology

    Odense, Region Syddanmark, 5000

    Dagmar Beier, M.D., Ph.D., dagmar.beier@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

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

Read the detailed description

This study is a multicenter, prospective, population-based cohort study with consecutive inclusion of patients in which the diagnosis of IIH is suspected. This study is carried out in collaboration between the Danish Headache Center, Rigshospitalet-Glostrup, and the Neurological Department at Odense University Hospital.

Patients are eligible for inclusion into the study if:

  1. IIH is suspected
  2. > 18 years old and able to provide written informed consent.

At baseline included patients will have:

A.) Medical history B.) Neurological, ophthalmological and general medical examination C.) Relevant neuro-imaging D.) Blood samples and lumbar puncture F.) Evaluation by other specialist, including neuro-psychologists, if appropriate.

Subsequently patients are divided into three sub-groups according to revised Friedmann criteria:

  1. Certain IIH or IIH-WOP
  2. Suspected, but unconfirmed, IIH
  3. IIH ruled out

Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.

Being tested
Standard treatment
Medical subject headings
Pseudotumor Cerebri

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard treatmentOther

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

Study groups in NCT04032379
Study groupRoleWhat they receive
Certain IIH or IIH-WOPAccording to revised diagnostic criteria, Friedmann, 2013.
Receives: Other: Standard treatment
Suspected IIHIIH is suspected, does not fulfill diagnostic criteria.
Receives: Other: Standard treatment
IIH ruled outPatients in whom another diagnosis is made.
Receives: Other: Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarkers of IIH (diagnostic and prognostic)

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

    Measured: 2 years

  2. Visual status at conclusion of study

    Assessment of visual fields

    Measured: 2 years

  3. Visual status at conclusion of study

    Assessment of OCT

    Measured: 2 years

  4. Visual status at conclusion of study

    Assessment of visual acuity

    Measured: 2 years

  5. Headache status at conclusion of study

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

    Measured: 2 years

  6. Biomarkers of IIH (diagnostic and prognostic)

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

    Measured: 2 years

Secondary outcomes (8)

  1. Baseline characteristics related to poor outcome

    Poor outcome is defined as either a.) Persistent visual field defects, decreased visual acuity after 12 months and or b.) Headache >= 15 days per month after 12 months

    Measured: 1 year

  2. Results of neuropsychological evaluations

    Standard neuro-psychological tests

    Measured: 1 year

  3. Treatment and follow-up

    Length and type of treatment and follow-up

    Measured: 3 years

  4. Baseline characteristics related to IIH diagnosis

    Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.

    Measured: 2 years

  5. Weight change in a standard care program

    Unit of measurement is BMI

    Measured: 2 years

  6. Diagnostic criteria and their use in the clinical setting

    Revised Friedmann criteria of 2013

    Measured: 2 years

  7. Clinical markers related to disease activity

    Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.

    Measured: 2 years

  8. Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline

    ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2019
  2. Study start14 Feb 2018
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04032379
Sponsor's protocol ID
S-20170058
Status last verified
Mar 2023
First submitted
12 Jul 2019
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3395261

  • 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.

    PubMed 24756302

  • 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.

    PubMed 25228684

  • 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.

    PubMed 25070715

  • 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.

    PubMed 24713214

  • 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.

    PubMed 19222592

  • 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.

    PubMed 23165338

  • 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.

    PubMed 23771276

  • 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.

    PubMed 26460890

  • 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.

    PubMed 38663903

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Intracranial Hypertension, run by Danish Headache Center at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johanne Severinsen, M.D. (004538633553, johanne.juhl.severinsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarkers of IIH (diagnostic and prognostic) (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032379, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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