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Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032379
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Johanne Severinsen, Danish Headache Center

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


Condition or disease Intervention/treatment
Benign Intracranial Hypertension Other: Standard treatment

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Group/Cohort Intervention/treatment
Certain IIH or IIH-WOP
According to revised diagnostic criteria, Friedmann, 2013.
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.

Suspected IIH
IIH is suspected, does not fulfill diagnostic criteria.
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.

IIH ruled out
Patients in whom another diagnosis is made.
Other: Standard treatment
No intervention, some patients have additional neuro-psychological testing.




Primary Outcome Measures :
  1. Biomarkers of IIH (diagnostic and prognostic) [ Time Frame: 2 years ]
    Analyses of CSF and blood for protein-markers (method: Proteomics)

  2. Visual status at conclusion of study [ Time Frame: 2 years ]
    Assessment of visual fields

  3. Visual status at conclusion of study [ Time Frame: 2 years ]
    Assessment of OCT

  4. Visual status at conclusion of study [ Time Frame: 2 years ]
    Assessment of visual acuity

  5. Headache status at conclusion of study [ Time Frame: 2 years ]
    Prevalence of chronic headache (>=15 headache days per month)

  6. Biomarkers of IIH (diagnostic and prognostic) [ Time Frame: 2 years ]
    Analyses of CSF and blood for markers of metabolism (method: Metabolomics)


Secondary Outcome Measures :
  1. Baseline characteristics related to poor outcome [ Time Frame: 1 year ]
    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

  2. Results of neuropsychological evaluations [ Time Frame: 1 year ]
    Standard neuro-psychological tests

  3. Treatment and follow-up [ Time Frame: 3 years ]
    Length and type of treatment and follow-up

  4. Baseline characteristics related to IIH diagnosis [ Time Frame: 2 years ]
    Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.

  5. Weight change in a standard care program [ Time Frame: 2 years ]
    Unit of measurement is BMI

  6. Diagnostic criteria and their use in the clinical setting [ Time Frame: 2 years ]
    Revised Friedmann criteria of 2013

  7. Clinical markers related to disease activity [ Time Frame: 2 years ]
    Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.

  8. Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [ Time Frame: 2 years ]
    ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O


Biospecimen Retention:   Samples Without DNA
Plasma Serum Cerebrospinalfluid (supernatant)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032379


Contacts
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Contact: Johanne Severinsen, M.D. 004538633553 johanne.juhl.severinsen@regionh.dk

Locations
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Denmark
The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Johanne Severinsen, M.D.       johanne.juhl.severinsen@regionh.dk   
Odense University Hospital, Department of Neurology Recruiting
Odense, Region Syddanmark, Denmark, 5000
Contact: Dagmar Beier, M.D., Ph.D.       dagmar.beier@rsyd.dk   
Sponsors and Collaborators
Danish Headache Center
Odense University Hospital
Investigators
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Study Director: Rigmor Jensen, M.D., Dr.Med. The Danish Headache Center, Rigshospitalet-Glostrup
Study Director: Dagmar Beier, M.D., Ph.D. Odense University Hospital

Publications:

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Responsible Party: Johanne Severinsen, Clinical assistant, M.D., Danish Headache Center
ClinicalTrials.gov Identifier: NCT04032379    
Other Study ID Numbers: S-20170058
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases