Idiopathic Intracranial Hypertension
Conditions
Keywords
Pseudotumor Cerebri, Benign Intracranial Hypertension, Headaches, Tinnitus, Papilledema, Blindness, Optic Disk, Intracranial Hypertension, Clinical Trial, Phase 2, 11beta-Hydroxysteroid Dehydrogenase Type 1, Obesity
Brief summary
Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH) IIH is a condition of young, overweight women with characteristic raised intracranial pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there is little evidence for the treatments used for IIH. Weight control appears the most effective method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our previous research suggests it may influence the production of brain fluid(cerebrospinal fluid or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased intracranial pressure. Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter the study if they are between 18-55 years old with acute (\<6 months) IIH, signs of active disease (papilloedema and raised CSF pressure (\>25 cmH20)), no other major illnesses and have no plans for pregnancy during the study period. This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial. It will be conducted at the University Hospital Birmingham and the University of Birmingham will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a potential improvement in their condition. We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and consequently treat patients with IIH, thus opening a new and entirely novel therapeutic avenue.
Interventions
DRUGAZD4017
OTHERPlacebo
Matched placebo (matched to AZD4017 arm)
Sponsors
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures. * Female patients between 18 and 55 years * Diagnosis of IIH by the Modified Dandy criteria1 with: 1. acute (\<6 months), 2. active disease (papilloedema (Frisen grade greater than or equal to 1), 3. significantly raised ICP \> 25cmH2O) 4. normal brain imaging during previous routine diagnostic work up (evaluated by either magnetic resonance venography or computerised tomography with venography). * Patients must be willing to use one form of highly effective non-hormonal contraception. This would include: 1. a vasectomised partner (sole partner) or tubal occlusion or 2. copper containing IUD - all of which should be used in addition to a diaphragm or cervical/vault caps with barrier contraceptive (condom or spermicidal foam/gel/film/suppository) 3. true abstinence (when this is in line with the preferred and usual lifestyle of the subject. Women should have been stable on their chosen method of birth control for a minimum of 2 months before entering the trial. Patients must agree to undergo a β-hCG pregnancy test and urine dipstick test at screening and urine dipstick testing at all trial visits (including the final follow up visit 4 weeks after discontinuation of study treatment). Note: the use of contraception and pregnancy testing would not be required if the screening LH/FSH levels demonstrate the patient is post-menopausal. * Participants are able to continue other medications to treat their IIH e.g. acetazolamide, diuretics but this dose must remain fixed throughout the study. * Patients who take aspirin therapy will be asked to discontinue aspirin 3 days prior to fat and skin biopsy if clinically safe to do so. * Placebo treatment for the duration of the study must not be considered detrimental to the patient. * Must be able to understand the consent form and comply with study requirements.
Exclusion criteria
* Optic nerve sheath fenestration. * Patients who undergo CSF shunt insertion (which is not elective or pre- planned) during the study, as a result of deterioration will be withdrawn from the study. * Abnormal neurological examination (aside from papilloedema and consequent visual loss or VI nerve palsy). * Subjects with a secondary cause of raised intracranial pressure will be excluded (venous thrombosis, anaemia, drug causes (lithium, vitamin A, tetracycline or others deems responsible for the condition). * Abnormal CSF contents (except for that compatible with a traumatic LP). * Unable to perform a visual field reliably. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Pressure | 12 weeks | ICP measured by lumbar puncture in cmCSF as the change from week 0 and week 12 of treatment, measured at baseline and week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric Measurements (BMI) | 12 weeks | The temporal change in Body Mass Index (in kg/m\^2) over 12 weeks of treatment, measured at baseline and week 12 |
| Visual Loss | 12 weeks | The temporal change in IIH symptoms (presence or absence of visual loss, measured at baseline and week 12 |
| Diplopia | 12 weeks | The temporal change in IIH symptoms (presence or absence of diplopia, measured at baseline and week 12 |
| Visual Obscuration | 12 weeks | The temporal change in IIH symptoms (presence or absence of visual obscuration, measured at baseline and week 12 |
| Headache | 12 weeks | The temporal change in IIH symptoms (presence or absence of headache, measured at baseline and week 12 |
| Visual Acuity | 12 weeks | The temporal change in IIH visual function in both eyes (measured by LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, between the baseline to week 12, measured at baseline and week 12 |
| Tinnitus | 12 weeks | The temporal change in IIH symptoms (presence or absence of tinnitus), measured at baseline and week 12 |
| Headache-associated Disability | 12 weeks | The change in headache associated disability through the headache impact test-6 score (HIT 6), measured at baseline and week 12. This is scored 11-66 with higher scores indicating worse headache. |
| Adverse Events | 16 weeks | The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. |
| Serious Adverse Events | 16 weeks | The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. |
| OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | 12 weeks | The temporal change in OCT Total average retinal nerve fibre layer thickness (μm), measured at baseline and week 12 |
| Visual Field Mean Deviation | 12 weeks | The temporal change in IIH visual function in both eyes using automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation between the baseline to week 12 |
| Log Contrast Sensitivity | 12 weeks | The temporal change in IIH visual function in both eyes using a Pelli-Robson chart to evaluate log contrast sensitivity between the baseline to week 12 |
| Papilloedema | 12 weeks | The temporal change in papilloedema (evaluated at the end of trial follow up using stereoscopic fundus photographs by masked neuro-ophthalmologists to grade the images according to Frisen classification) measured at baseline and week 12. There are 6 grades, 0-5, 5 being the worst. The modified Frisén scale for grading papilledema using fundus photography is as follows: Grade 1 - C-Shaped halo with a temporal gap Grade 2 - The halo becomes circumferential Grade 3 - Loss of major vessels as they leave the disc Grade 4 - Loss of major vessels on the disc Grade 5 - Criteria of Grade IV + partial or total obscuration of all vessels on the disc For further details see e.g. Scott, C.J., et al., Diagnosis and grading of papilledema in patients with raised intracranial pressure using optical coherence tomography vs clinical expert assessment using a clinical staging scale. Arch. Ophthalmol, 2010. 128(6): p. 705-711. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matched placebo tablet B.D for 12 weeks
Placebo: Matched placebo (matched to AZD4017 arm) | 14 |
| AZD4017 (11b-HSD1 Inhibitor) AZD4017 400mg tablet B.D. for 12 weeks
AZD4017 | 17 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient withdrawn day after randomisation as found to be ineligible. Did not return for follow up. | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | AZD4017 (11b-HSD1 Inhibitor) |
|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 6.9 | 32.4 years STANDARD_DEVIATION 8 | 30.1 years STANDARD_DEVIATION 5.9 |
| BMI (kg/m^2) | 39.2 kg/m^2 STANDARD_DEVIATION 12.6 | 41.2 kg/m^2 STANDARD_DEVIATION 16.6 | 37.3 kg/m^2 STANDARD_DEVIATION 7.2 |
| Frisen grading (Worst eye) 1 | 6 Participants | 2 Participants | 4 Participants |
| Frisen grading (Worst eye) 2 | 14 Participants | 5 Participants | 9 Participants |
| Frisen grading (Worst eye) 3 | 3 Participants | 3 Participants | 0 Participants |
| Frisen grading (Worst eye) 4 | 3 Participants | 1 Participants | 2 Participants |
| Frisen grading (Worst eye) 5 | 1 Participants | 0 Participants | 1 Participants |
| Frisen grading (Worst eye) missing | 1 Participants | 1 Participants | 0 Participants |
| Headache Impact Test 6 (HIT-6) Score | 63.6 HIT-6 score (higher is worse) STANDARD_DEVIATION 8 | 63.4 HIT-6 score (higher is worse) STANDARD_DEVIATION 8.1 | 63.8 HIT-6 score (higher is worse) STANDARD_DEVIATION 8.2 |
| Opening LP pressure (cmCSF) | 33.3 cmCSF STANDARD_DEVIATION 5.6 | 32.7 cmCSF STANDARD_DEVIATION 4.8 | 33.7 cmCSF STANDARD_DEVIATION 6.3 |
| Presence of diplopia Absence | 19 Participants | 9 Participants | 10 Participants |
| Presence of diplopia Presence | 12 Participants | 5 Participants | 7 Participants |
| Presence of headache Absence | 1 Participants | 0 Participants | 1 Participants |
| Presence of headache Presence | 30 Participants | 14 Participants | 16 Participants |
| Presence of Pulsatile Tinnitus Absence | 6 Participants | 1 Participants | 5 Participants |
| Presence of Pulsatile Tinnitus Presence | 25 Participants | 13 Participants | 12 Participants |
| Presence of visual loss Absence | 19 Participants | 6 Participants | 13 Participants |
| Presence of visual loss Presence | 12 Participants | 8 Participants | 4 Participants |
| Presence of Visual obscuration Absence | 19 Participants | 8 Participants | 11 Participants |
| Presence of Visual obscuration Presence | 12 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian/Asian British - Other Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Asian British - Pakistani | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White British | 29 Participants | 13 Participants | 16 Participants |
| Region of Enrollment United Kingdom | 31 participants | 14 participants | 17 participants |
| Sex: Female, Male Female | 31 Participants | 14 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Taking acetazolamide (yes/no) No | 21 Participants | 10 Participants | 11 Participants |
| Taking acetazolamide (yes/no) Yes | 10 Participants | 4 Participants | 6 Participants |
| Weight (kg) | 102.6 kg STANDARD_DEVIATION 32.3 | 108 kg STANDARD_DEVIATION 42.3 | 97.9 kg STANDARD_DEVIATION 21.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 17 |
| other Total, other adverse events | 11 / 14 | 16 / 17 |
| serious Total, serious adverse events | 1 / 14 | 0 / 17 |
Outcome results
Primary
Intracranial Pressure
ICP measured by lumbar puncture in cmCSF as the change from week 0 and week 12 of treatment, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Intracranial Pressure | -0.3 cmCSF | Standard Deviation 5.9 |
| AZD4017 (11b-HSD1 Inhibitor) | Intracranial Pressure | -4.3 cmCSF | Standard Deviation 5.7 |
Secondary
Adverse Events
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Adverse Events | 0 AEs related to intervention |
| AZD4017 (11b-HSD1 Inhibitor) | Adverse Events | 9 AEs related to intervention |
Secondary
Anthropometric Measurements (BMI)
The temporal change in Body Mass Index (in kg/m\^2) over 12 weeks of treatment, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anthropometric Measurements (BMI) | 37.4 kg/m^2 | Standard Deviation 8.4 |
| AZD4017 (11b-HSD1 Inhibitor) | Anthropometric Measurements (BMI) | 37.5 kg/m^2 | Standard Deviation 6.9 |
Secondary
Diplopia
The temporal change in IIH symptoms (presence or absence of diplopia, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Diplopia | Presence | 1 Participants |
| Placebo | Diplopia | Absence | 11 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Diplopia | Presence | 2 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Diplopia | Absence | 15 Participants |
Secondary
Headache
The temporal change in IIH symptoms (presence or absence of headache, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Headache | Presence | 10 Participants |
| Placebo | Headache | Absence | 2 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Headache | Presence | 13 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Headache | Absence | 4 Participants |
Secondary
Headache-associated Disability
The change in headache associated disability through the headache impact test-6 score (HIT 6), measured at baseline and week 12. This is scored 11-66 with higher scores indicating worse headache.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Headache-associated Disability | 59.8 Score on HIT-6 scale | Standard Error 7.9 |
| AZD4017 (11b-HSD1 Inhibitor) | Headache-associated Disability | 60.1 Score on HIT-6 scale | Standard Error 11.6 |
Secondary
Log Contrast Sensitivity
The temporal change in IIH visual function in both eyes using a Pelli-Robson chart to evaluate log contrast sensitivity between the baseline to week 12
Time frame: 12 weeks
Population: NB: assessment at 12 weeks not completed for 2 participants (placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Log Contrast Sensitivity | Baseline LCS worst eye | 1.63 Log contrast senstivity | Standard Deviation 0.16 |
| Placebo | Log Contrast Sensitivity | Week 12 LCS worst eye | 1.66 Log contrast senstivity | Standard Deviation 0.12 |
| AZD4017 (11b-HSD1 Inhibitor) | Log Contrast Sensitivity | Baseline LCS worst eye | 1.63 Log contrast senstivity | Standard Deviation 0.22 |
| AZD4017 (11b-HSD1 Inhibitor) | Log Contrast Sensitivity | Week 12 LCS worst eye | 1.65 Log contrast senstivity | Standard Deviation 0.15 |
Secondary
OCT Total Average Retinal Nerve Fibre Layer Thickness (μm)
The temporal change in OCT Total average retinal nerve fibre layer thickness (μm), measured at baseline and week 12
Time frame: 12 weeks
Population: NB: assessment missed in participants of both arms due to centre capacity.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | Total average retinal nerve fibre layer baseline worst ete | 158.4 μm | Standard Deviation 83 |
| Placebo | OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | Total average retinal nerve fibre layer week 12 worst eye | 143.2 μm | Standard Deviation 78.7 |
| AZD4017 (11b-HSD1 Inhibitor) | OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | Total average retinal nerve fibre layer baseline worst ete | 152 μm | Standard Deviation 68.7 |
| AZD4017 (11b-HSD1 Inhibitor) | OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | Total average retinal nerve fibre layer week 12 worst eye | 139.7 μm | Standard Deviation 56.3 |
Secondary
Papilloedema
The temporal change in papilloedema (evaluated at the end of trial follow up using stereoscopic fundus photographs by masked neuro-ophthalmologists to grade the images according to Frisen classification) measured at baseline and week 12. There are 6 grades, 0-5, 5 being the worst. The modified Frisén scale for grading papilledema using fundus photography is as follows: Grade 1 - C-Shaped halo with a temporal gap Grade 2 - The halo becomes circumferential Grade 3 - Loss of major vessels as they leave the disc Grade 4 - Loss of major vessels on the disc Grade 5 - Criteria of Grade IV + partial or total obscuration of all vessels on the disc For further details see e.g. Scott, C.J., et al., Diagnosis and grading of papilledema in patients with raised intracranial pressure using optical coherence tomography vs clinical expert assessment using a clinical staging scale. Arch. Ophthalmol, 2010. 128(6): p. 705-711.
Time frame: 12 weeks
Population: NB: assessment missed for one participant at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Papilloedema | Frisen grade 0 baseline | 0 Participants |
| Placebo | Papilloedema | Frisen grade 0 week 12 | 0 Participants |
| Placebo | Papilloedema | Frisen grade 1 baseline | 2 Participants |
| Placebo | Papilloedema | Frisen grade 1 week 12 | 2 Participants |
| Placebo | Papilloedema | Frisen grade 2 baseline | 5 Participants |
| Placebo | Papilloedema | Frisen grade 2 week 12 | 6 Participants |
| Placebo | Papilloedema | Frisen grade 3 baseline | 3 Participants |
| Placebo | Papilloedema | Frisen grade 3 week 12 | 3 Participants |
| Placebo | Papilloedema | Frisen grade 4 baseline | 1 Participants |
| Placebo | Papilloedema | Frisen grade 4 week 12 | 1 Participants |
| Placebo | Papilloedema | Frisen grade 5 baseline | 0 Participants |
| Placebo | Papilloedema | Frisen grade 5 week 12 | 0 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 5 baseline | 1 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 0 baseline | 0 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 3 baseline | 0 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 0 week 12 | 2 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 4 week 12 | 1 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 1 baseline | 4 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 3 week 12 | 0 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 1 week 12 | 5 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 5 week 12 | 0 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 2 baseline | 9 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 4 baseline | 2 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Papilloedema | Frisen grade 2 week 12 | 8 Participants |
Secondary
Serious Adverse Events
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Serious Adverse Events | 1 Serious adverse events |
| AZD4017 (11b-HSD1 Inhibitor) | Serious Adverse Events | 0 Serious adverse events |
Secondary
Tinnitus
The temporal change in IIH symptoms (presence or absence of tinnitus), measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Tinnitus | Presence | 7 Participants |
| Placebo | Tinnitus | Absence | 5 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Tinnitus | Presence | 9 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Tinnitus | Absence | 8 Participants |
Secondary
Visual Acuity
The temporal change in IIH visual function in both eyes (measured by LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, between the baseline to week 12, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Acuity | Baseline LVA worst eye | 0.13 LogMAR (log of the minimum angle of reso | Standard Deviation 0.22 |
| Placebo | Visual Acuity | Week 12 LVA worst eye | 0.09 LogMAR (log of the minimum angle of reso | Standard Deviation 0.18 |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Acuity | Baseline LVA worst eye | 0.08 LogMAR (log of the minimum angle of reso | Standard Deviation 0.23 |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Acuity | Week 12 LVA worst eye | 0.06 LogMAR (log of the minimum angle of reso | Standard Deviation 0.15 |
Secondary
Visual Field Mean Deviation
The temporal change in IIH visual function in both eyes using automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation between the baseline to week 12
Time frame: 12 weeks
Population: NB: assessment at 12 weeks not completed for 2 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Field Mean Deviation | Baseline MD worst eye | -3.4 Visual field mean deviation | Standard Deviation 6.8 |
| Placebo | Visual Field Mean Deviation | Week 12 MD worst eye | -2.2 Visual field mean deviation | Standard Deviation 3.1 |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Field Mean Deviation | Baseline MD worst eye | -6.1 Visual field mean deviation | Standard Deviation 5.4 |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Field Mean Deviation | Week 12 MD worst eye | -3.4 Visual field mean deviation | Standard Deviation 3.2 |
Secondary
Visual Loss
The temporal change in IIH symptoms (presence or absence of visual loss, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Visual Loss | Presence | 7 Participants |
| Placebo | Visual Loss | Absence | 4 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Loss | Presence | 6 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Loss | Absence | 11 Participants |
Secondary
Visual Obscuration
The temporal change in IIH symptoms (presence or absence of visual obscuration, measured at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Visual Obscuration | Presence | 2 Participants |
| Placebo | Visual Obscuration | Absence | 9 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Obscuration | Presence | 2 Participants |
| AZD4017 (11b-HSD1 Inhibitor) | Visual Obscuration | Absence | 15 Participants |