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Idiopathic Intracranial HypertensionPhase 2/3IIHTTNCT01003639

Idiopathic Intracranial Hypertension Treatment Trial

A Phase 2/3 study testing Acetazolamide and Formal weight loss counselling program in people with Idiopathic Intracranial Hypertension, run by St. Luke's-Roosevelt Hospital Center at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Idiopathic Intracranial Hypertension
What is being tested?
Acetazolamide and Formal weight loss counselling program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
41 sitesin 2 countries
Study dates
Jan 2010to Jan 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Diagnosis of IIH by modified Dandy criteria Signs and symptoms of increased intracranial pressure Absence of localizing findings on neurologic examination Absence of deformity, displacement, or obstruction of the ventricular system and otherwise normal neurodiagnostic studies, except for evidence of increased cerebrospinal fluid pressure (>200 mm water). Abnormal neuroimaging except for empty sella turcica, optic nerve sheath enlargement, and smooth-walled non flow-related venous sinus stenosis or collapse106 should lead to another diagnosis Awake and alert No other cause of increased intracranial pressure present
  • Diagnosis of IIH for 6 weeks or less
  • Age 18 to 60 years at time of diagnosis
  • Reproducible visual loss present on automated perimetry (in eye with greatest loss)
  • Average PMD -2 dB up to -5 dB in the worst eye
  • Presence of bilateral papilledema
  • Able to provide informed consent
  • Women of child-bearing potential must use an acceptable form of birth control during the intervention phase of the study. Acceptable forms include oral contraceptives, transdermal contraceptives,

Who cannot join

  • Total treatment of IIH of more than two weeks (except for acetazolamide which is limited to 1 week). For every day on treatment there must be a one-day washout period.
  • Previous surgery for IIH including optic nerve sheath fenestration, CSF shunting procedures, subtemporal decompression and venous stenting
  • Previous gastric bypass surgery
  • Abnormalities on neurologic examination aside from papilledema and its related visual loss or VI nerve paresis
  • Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, unfolded optic nerve sheaths, flattened sclera, or smooth- walled venous stenosis
  • CSF pressure less than 200 mm water (patients may have repeat CSF pressure measurements if the first is normal or no opening pressure obtained)
Show all 9Show fewer
  • Abnormal CSF contents: increased cells: > 5 cells, elevated protein:
  • > 45 mg%, low glucose: < 30 mg% (If the lumbar puncture produces a cell count compatible with a traumatic needle insertion, the patient does not need to be excluded if the CSF WBC after correction is 5 wbc/mm3 or less- see Operations Manual for calculation) 8. Intraocular pressure currently > 28 mm Hg or > 30 mm Hg at any time in the past 9. Refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye with the following exceptions: Subjects with myopia of >-6.00 D sphere but less than or equal to - 8.00 D sphere are eligible if 1)there are no abnormalities on ophthalmoscopy or fundus photos related to myopia that are associated with visual loss (such as staphyloma, retinal thinning in the posterior pole or more than mild optic disc tilt), and 2) the subject wears a contact lens for all perimetry examinations with the appropriate correction. If either the Site Investigator or the PRC director (or his designate) decides there are optic fundus abnormalities of myopia that are associated with visual loss, then 9. Subjects with hyperopia of > +6.00 D but less than or equal to
  • 8.00 D sphere are eligible if 1) there is an unambiguous characteristic halo of peripapillary edema as opposed to features of a small crowded disc or other hyperopic change related to visual loss determined by the site investigator or the PRC director (or his designate) and 2) the subject wears a contact le 10. Other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis 11. Optic disc drusen on exam or in previous history 12. Presence of diagnosed untreated obstructive sleep apnea 13. Inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors) 14. Abnormal blood work-up indicating a medical or systemic condition associated with raised ICP 15. Study blood results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the Site Investigator's judgment 16. Type I diabetes or the presence of diabetic retinopathy 17. Exposure to a drug, substance or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines (see table in Operations Manual for conditions and drugs) 18. Other condition requiring diuretics, oral, I.V. or injectable steroids or other pressure lowering agents including topiramate (nasal, inhaled, or topical steroids are allowed since the systemic effects are small) 19. Presence of a medical condition such as renal stones that would contraindicate use of the study drug (acetazolamide) 20. Pregnancy or unwillingness for subject of childbearing potential to use contraception during the first year of the study 21. Breastfeeding mothers are excluded from participation unless willing to discontinue breastfeeding by the baseline visit 22. Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless) 23. Anticipation of a move from the site area within six months and unwillingness to return for follow-up at an IIHTT study site 24. Allergy to pupil dilating drops or narrow angles precluding safe dilation

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

United States39 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Greater Baltimore Medical Center Department Of Ophthamology

    Baltimore, Maryland, 21204

  • Johns Hopkins Universtiy - Wilmer Ophthamological Institute

    Baltimore, Maryland, 21287

  • Louisiana State University Health Sciences Center - Earl K. Long Medical Center

    Baton Rouge, Louisiana, 70810

  • Bethesda Neurology, LLC

    Bethesda, Maryland, 20814

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts Eye and Ear Infirmary - Neuro-Ophthamology Service

    Boston, Massachusetts, 02114

  • University of Virginia - Department of Ophthalmology

    Charlottesville, Virginia, 22903

  • Ohio State University

    Columbus, Ohio, 43212

  • Duke Eye Center

    Durham, North Carolina, 27710

  • Michigan State University Department of Neurology

    East Lansing, Michigan, 48823

  • The Methodist Hospital: Methodist Eye Associates

    Houston, Texas, 77030

  • Universtiy of Houston - University Eye Institute

    Houston, Texas, 77204

  • Department of Ophthamology and Visual Sciences, University of Iowa

    Iowa City, Iowa, 55242

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Doheny Eye Center, University of Southern California

    Los Angeles, California, 90033

  • Bascom Palmer Eye Institute, University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Eye and Ear Infirmary

    New York, New York, 10003

  • Weill Cornell Medical College

    New York, New York, 10021

  • The Mount Sinai Medical Center

    New York, New York, 10029

  • New Jersey Medical School/University Physicians Associates of New Jersey

    Newark, New Jersey, 07103

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • University of Illinois

    Peoria, Illinois, 61637

  • University of Pennsylvania, Department of Ophthamology

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University - Casey Eye Institute

    Portland, Oregon, 97239

  • Raleigh Neurology Associates, PA

    Raleigh, North Carolina, 27607

  • University of Rochester - Flaum Eye Institute

    Rochester, New York, 14642

  • William Beaumont Hosptial Research Institute

    Royal Oak, Michigan, 48073

  • University of Utah, John A. Moran Eye Center

    Salt Lake City, Utah, 84132

  • University of Texas Science Center

    San Antonio, Texas, 78229

  • Swedish Medical Center

    Seattle, Washington, 98014

  • Saint Louis University Eye Institute

    St Louis, Missouri, 63104

  • University of St. Louis

    St Louis, Missouri, 63110

  • Stony Brook University

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University, Neurology Medical Service Group

    Syracuse, New York, 13202

  • Neuro-Ophthamology & Balance Disorders Clinic

    Tallahassee, Florida, 32308

  • The Eye Care Group, PC

    Waterbury, Connecticut, 06708

  • Wake Forrest University Eye Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada2 sites

  • University of Calgary: Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

  • Queen's University - Hotel Dieu Hospital

    Kingston, Ontario, K7L 5G2

Other trials in Canada

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss

Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).

Read the detailed description

Clinical Phase: Phase II Investigators: NORDIC Network sites Study Centers: 38 study centers Coordinating Center - University of Rochester Statistical Center - University of Rochester Study Period Planned enrollment duration: 2 years Planned duration of treatment: 6 months followed by open-label treatment Planned duration of follow-up: 4.5 years Study Objectives: The primary objective is determining the efficacy of diet plus acetazolamide vs diet alone in reducing or reversing visual loss in subjects with mild visual loss.

The secondary objective is to identify proteomic and genetic risk factors for IIH by screening a large cohort of IIH patients and controls.

Study Population This project will enroll 166 individuals with IIH who are 18-60 years of age. We anticipate that the population will be primarily composed of women in the childbearing years that are overweight. 154 control subjects will also be enrolled. Control subjects will be matched as closely as possibly by age, sex, race, ethnicity and weight to subjects enrolled at the site.

Study Design: Multi-center, double-blind randomized intervention study followed by a 4-year observation period. Subjects will be randomized to diet and acetazolamide or diet and placebo. The study will use 250 mg acetazolamide or matching placebo tablets taken with food at meals and at bedtime. The subject will begin with one tablet four times daily, at meals and at bedtime for the first week. Beginning on Day 7, subjects will increase the dosage by 1 tablet every 4 days until a final dosage of 4 tablets four times daily (4 grams) is reached or side effects prohibit increasing the dosage further. If the study drug is not tolerated at a dose of 250 mg, then 125 mg (1/2 tablet) will be tried. If this is not tolerated, no pharmacologic treatment will be given.

After the 6 month visit, all subjects will transition from study medication to acetazolamide (open label) by replacing one tablet of study drug with 250 mg of acetazolamide every four days. The acetazolamide dose will be titrated in a manner similar to the initial study drug schedule to the maximum tolerated dose of acetazolamide. To avoid treating subjects (who may have initially been assigned to placebo) unnecessarily, any subject with grade 0-1 papilledema will be tapered off study drug but not placed on acetazolamide unless they have persisting headaches or pulse-synchronous tinnitus. If so, they will be placed on acetazolamide regardless of the low papilledema grade. At the 9-month follow-up visit, we will make sure that the subjects' vision is stable after the transition off of study medication. After the 9 month visit, medication will be prescribed by the subject's treating physician. The intervention phase of the study will end at the subject's 12 month visit and subjects will be invited to participate in the observational phase of the study and consented to do so if willing.

Number of Subjects: 166 subjects with IIH and 154 control subjects Main Inclusion Criteria

  1. Diagnosis of IIH by modified Dandy criteria
  2. Diagnosis of IIH for 6 weeks or less
  3. Age 18 to 60 years at time of diagnosis
  4. Reproducible visual loss present on automated perimetry (in eye with greatest loss)*
  5. perimetric mean deviation (PMD) -2 decibel (dB) up to -5 dB in the worst eye
  6. Presence of bilateral papilledema
  7. Able to provide informed consent or parental permission with appropriate assent

Main Exclusion Criteria

  1. Total treatment of IIH of more than one week in the past six weeks
  2. Corticosteroids or surgery used for IIH treatment within the past two months
  3. Abnormalities on neurologic examination aside from papilledema and its related visual loss or VI nerve paresis (unless pre-existing and unrelated to IIH)
  4. Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, dilated optic nerve sheath, flattened sclera, or secondary Chiari
  5. CSF pressure less than 200 mm water (patients may have repeat CSF pressure measurements if the first is normal or no opening pressure obtained)
  6. Abnormal CSF contents (increased cells, elevated protein, low glucose)
  7. Intraocular pressure currently > 28 mm Hg or > 30 mm Hg at any time in the past
  8. Refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye
  9. Other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis
  10. Inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors
  11. Abnormal blood work-up indicating a medical or systemic condition associated with raised intracranial pressure (ICP)
  12. Exposure to a drug, substance or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, tetracycline, steroid withdrawal (see table in Manual of Procedures (MOP) for conditions and drugs)
  13. Other condition requiring diuretics, steroids or other pressure lowering agents including topiramate
  14. Presence of a medical condition such as renal stones that would contraindicate use of the study drugs (acetazolamide)
  15. Pregnancy or unwillingness for subject with childbearing potential to use contraception during the first year of the study
  16. Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless)
  17. Anticipation of a move from the site area within six months and unwillingness to return for follow-up.

Route and Dosage Form: 250 mg acetazolamide tablets or matching placebo taken with food 4 times daily. Subjects will titrate to a maximum dose of 4 tablets 4 times daily (4 grams) as tolerated. If a subject is not able to tolerate a dose of 250 mg, 125 mg (1/2 tablet) may be tried. If this is not tolerated, no pharmacologic treatment will be given.

Duration of Treatment: 6 months of randomized treatment followed by open label acetazolamide treatment. After the 9-month visit medication will be prescribed by the subject's treating physician. The intervention phase of the study will end at Month 12 and the subject invited to continue in the observational phase.

Primary Outcome Measure(s): The primary outcome measure is the change from baseline to Month 6 in PMD (perimetric mean deviation) in the eye with the most severe initial visual loss.

Secondary Outcome Measure: CSF pressure measurement by lumbar puncture Number of abnormal perimetry test locations Visual field examination ratings (improved, remained the same, or worsened) Papilledema grade QOL assessments Dietary Outcomes (BMI, Waist circumference, urinary sodium) Safety Outcomes: Adverse events will be tabulated by treatment group, severity, and perceived relationship to the study intervention Sample Size Considerations

Being tested
Acetazolamide, Placebo, Formal weight loss counselling program
Keywords
papilledema, vision loss, headache, obesity, women, diplopia, tinnitus
Medical subject headings
Pseudotumor Cerebri, Papilledema, Vision Disorders, Headache, Obesity, Diplopia, Tinnitus

What participants receive

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

  • AcetazolamideDrug

    Also called naproxen, acetaminophen, aspirin, ibuprofen

    Subjects will begin with four 250 mg tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.

  • PlaceboDrug

    Also called naproxen, acetaminophen, aspirin, ibuprofen

    Subjects will begin with four tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.

  • Formal weight loss counselling programBehavioural

    Also called naproxen, acetaminophen, aspirin, ibuprofen

    Teleconference, web-based from central location, using site visits and subject self-assessment tools

Study groups in NCT01003639
Study groupRoleWhat they receive
AcetazolamideActive comparatorAcetazolamide given in escalating doses
Receives: Drug: Acetazolamide; Behavioral: Formal weight loss counselling program
Sugar pillPlacebo comparatorGiven in escalating "dose" (number of pill)
Receives: Drug: Placebo; Behavioral: Formal weight loss counselling program

What is being measured

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

  1. Mean Change in Perimetric Mean Deviation

    Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss.

    Measured: base line and 6 months

Secondary outcomes (3)

  1. Mean Change of Papilledema Grade on Fundus Photography

    Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema.

    Measured: Baseline and 6 Months

  2. Visual Function Questionnaire (VFQ-25)

    Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life)

    Measured: baseline

  3. Visual Acuity (No. of Correct Letters)

    Measured: Baseline

Timeline

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

  1. First posted29 Oct 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2013
  4. Study completionJan 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003639
Sponsor's protocol ID
NORDIC01
Other IDs
1U10EY017281-01A1, 1U10EY017387-01A1
Acronym
IIHTT
Status last verified
Nov 2018
First submitted
28 Oct 2009
Last updated
12 Dec 2018
Data monitoring committee
Yes

Publications

  • NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee; Wall M, McDermott MP, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, Kupersmith MJ. Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. JAMA. 2014 Apr 23-30;311(16):1641-51. doi: 10.1001/jama.2014.3312.

    PubMed 24756514

  • Wang JK, Kardon RH, Ledolter J, Sibony PA, Kupersmith MJ, Garvin MK; OCT Sub-Study Committee and the NORDIC Idiopathic Intracranial Hypertension Study Group. Peripapillary Retinal Pigment Epithelium Layer Shape Changes From Acetazolamide Treatment in the Idiopathic Intracranial Hypertension Treatment Trial. Invest Ophthalmol Vis Sci. 2017 May 1;58(5):2554-2565. doi: 10.1167/iovs.16-21089.

    PubMed 28492874

  • Wall M, Thurtell MJ; NORDIC Idiopathic Intracranial Hypertension Study Group. Optic disc haemorrhages at baseline as a risk factor for poor outcome in the Idiopathic Intracranial Hypertension Treatment Trial. Br J Ophthalmol. 2017 Sep;101(9):1256-1260. doi: 10.1136/bjophthalmol-2016-309852. Epub 2017 Jan 27.

    PubMed 28130349

  • Bruce BB, Digre KB, McDermott MP, Schron EB, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial. Neurology. 2016 Nov 1;87(18):1871-1877. doi: 10.1212/WNL.0000000000003280. Epub 2016 Sep 30.

    PubMed 27694262

  • Wall M, Johnson CA, Cello KE, Zamba KD, McDermott MP, Keltner JL; NORDIC Idiopathic Intracranial Hypertension Study Group. Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). Invest Ophthalmol Vis Sci. 2016 Mar;57(3):805-12. doi: 10.1167/iovs.15-18626.

    PubMed 26934136

  • Sibony PA, Kupersmith MJ; OCT Substudy Group of the NORDIC Idiopathic Intracranial Hypertension Treatment Trial. "Paton's Folds" Revisited: Peripapillary Wrinkles, Folds, and Creases in Papilledema. Ophthalmology. 2016 Jun;123(6):1397-9. doi: 10.1016/j.ophtha.2015.12.017. Epub 2016 Jan 14. No abstract available.

    PubMed 26778344

  • Cello KE, Keltner JL, Johnson CA, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Factors Affecting Visual Field Outcomes in the Idiopathic Intracranial Hypertension Treatment Trial. J Neuroophthalmol. 2016 Mar;36(1):6-12. doi: 10.1097/WNO.0000000000000327.

    PubMed 26618282

  • Sibony PA, Kupersmith MJ, Feldon SE, Wang JK, Garvin M; OCT Substudy Group for the NORDIC Idiopathic Intracranial Hypertension Treatment Trial. Retinal and Choroidal Folds in Papilledema. Invest Ophthalmol Vis Sci. 2015 Sep;56(10):5670-80. doi: 10.1167/iovs.15-17459.

    PubMed 26335066

  • Fischer WS, Wall M, McDermott MP, Kupersmith MJ, Feldon SE; NORDIC Idiopathic Intracranial Hypertension Study Group. Photographic Reading Center of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT): Methods and Baseline Results. Invest Ophthalmol Vis Sci. 2015 May;56(5):3292-303. doi: 10.1167/iovs.15-16465.

    PubMed 26024112

  • OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group; Auinger P, Durbin M, Feldon S, Garvin M, Kardon R, Keltner J, Kupersmith MJ, Sibony P, Plumb K, Wang JK, Werner JS. Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part II: correlations and relationship to clinical features. Invest Ophthalmol Vis Sci. 2014 Nov 4;55(12):8173-9. doi: 10.1167/iovs.14-14961.

    PubMed 25370513

  • OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group; Auinger P, Durbin M, Feldon S, Garvin M, Kardon R, Keltner J, Kupersmith M, Sibony P, Plumb K, Wang JK, Werner JS. Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part I: quality control, comparisons, and variability. Invest Ophthalmol Vis Sci. 2014 Nov 4;55(12):8180-8. doi: 10.1167/iovs.14-14960.

    PubMed 25370510

  • Keltner JL, Johnson CA, Cello KE, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Baseline visual field findings in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). Invest Ophthalmol Vis Sci. 2014 Apr 29;55(5):3200-7. doi: 10.1167/iovs.14-14243.

    PubMed 24781936

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Acetazolamide and Formal weight loss counselling program in people with Idiopathic Intracranial Hypertension, run by St. Luke's-Roosevelt Hospital Center at 41 sites in 2 countries.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Perimetric Mean Deviation (time frame: base line and 6 months). 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 NCT01003639, which also lists 13 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 12 Dec 2018.

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