Idiopathic Intracranial HypertensionPhase 2IIH:DTNCT02017444

Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension.

A Phase 2 study testing AZD4017 in people with Idiopathic Intracranial Hypertension, run by University of Birmingham at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years, women only
Conditions the study is for: Idiopathic Intracranial Hypertension
What is being tested?: AZD4017
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited Kingdom
Study dates: 25 Apr 2014to 19 Dec 2016
Phase: Phase 2
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 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

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:
acute (<6 months),
active disease (papilloedema (Frisen grade greater than or equal to 1),
significantly raised ICP > 25cmH2O)

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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:
a vasectomised partner (sole partner) or tubal occlusion or
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)
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.

Who cannot join

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.

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General Exclusion Criteria:
Positive hCG or urine dipstick pregnancy test or planning to conceive in the 4 study months.
Have eGFR calculated by MDRD equation of <60ml/min/1.73m2.
Have any endocrine disorder, e.g. thyroid dysfunction. This excludes PCOS where there is a known association to IIH.
Suspicion of or known Gilbert's disease.
CK >2 x ULN on 2 consecutive measurements.
ALT and/or AST >2 x ULN.
ALP > ULN.
Bilirubin (total) > 2 x ULN.
Must not have donated blood within 2 months of screening and avoid further donations for 4 months following the study.
Patient is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
Pregnant or breastfeeding mothers, unless willing to discontinue breastfeeding by the baseline visit.
Have uncontrolled systemic hypertension (BP >160/90), on 3 successive measurements on the morning of the screening visit.
Are receiving systemic (including vaginal/rectal) glucocorticoid treatment at the time of the screening visit. Note: Topical and inhaled are acceptable
Are taking any hormone-based medication, including hormone contraceptives, at the time of screening.
Are taking probenecid at the time of the screening visit.
Have any screening laboratory abnormality that, in the investigator's judgement, is considered to be clinically significant or any screening laboratory value which is outside the Sponsor specified ranges at screening; testing may be repeated but must be resolved prior to the baseline visit.
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation or will influence the results .
History or presence of significant gastrointestinal, hepatic , or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP as judged by the investigator.
Have been involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Have participated in any other interventional study within 1 month prior to the screening visit. Participation in the IIH National database or other observational studies will not prevent enrolment to this study.
Previous randomisation for treatment in the present study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University Hospital Birmingham (Queen Elizabeth Hospital)
Birmingham, West Midlands, B15 2TH

Other trials in United Kingdom

About this study

Official title: Lowering Intracranial Pressure in Idiopathic Intracranial Hypertension: Assessing the Therapeutic Efficacy and Safety of an 11β-hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017). Phase II Study.

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.

Conditions: Idiopathic Intracranial Hypertension
Being tested: AZD4017, Placebo
Keywords: Pseudotumor Cerebri, Benign Intracranial Hypertension, Headaches, Tinnitus, Papilledema, Blindness, Optic Disk, Intracranial Hypertension, Clinical Trial, Phase 2, 11beta-Hydroxysteroid Dehydrogenase Type 1, Obesity
Medical subject headings: Pseudotumor Cerebri, Headache, Tinnitus, Papilledema, Blindness, Intracranial Hypertension, Obesity

What participants receive

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

AZD4017Drug
Also called 11b-Hydroxysteroid dehydrogenase type 1 inhibitor
PlaceboOther
Matched placebo (matched to AZD4017 arm)

Study groups in NCT02017444
Study group	Role	What they receive
Placebo	Placebo comparator	Matched placebo tablet B.D for 12 weeks Receives: Other: Placebo
AZD4017 (11b-HSD1 inhibitor)	Active comparator	AZD4017 400mg tablet B.D. for 12 weeks Receives: Drug: AZD4017

What is being measured

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

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
Measured: 12 weeks

Secondary outcomes (14)

Tinnitus
The temporal change in IIH symptoms (presence or absence of tinnitus), measured at baseline and week 12
Measured: 12 weeks
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
Measured: 12 weeks
Visual Loss
The temporal change in IIH symptoms (presence or absence of visual loss, measured at baseline and week 12
Measured: 12 weeks
Diplopia
The temporal change in IIH symptoms (presence or absence of diplopia, measured at baseline and week 12
Measured: 12 weeks
Visual Obscuration
The temporal change in IIH symptoms (presence or absence of visual obscuration, measured at baseline and week 12
Measured: 12 weeks
Headache
The temporal change in IIH symptoms (presence or absence of headache, measured at baseline and week 12
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Adverse Events
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods.
Measured: 16 weeks
Serious Adverse Events
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods.
Measured: 16 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks

Timeline

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

25 Apr 201419 Dec 2016

First posted20 Dec 2013 (estimated)
Study start25 Apr 2014
Primary completion19 Dec 2016
Study completion19 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02017444
Sponsor's protocol ID: RG_13-022
Other IDs: 2013-003643-31, MR/K015184/1
Acronym: IIH:DT
Status last verified: Sep 2021
First submitted: 16 Dec 2013
Last updated: 27 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Gomez C, Alimajstorovic Z, Othonos N, Winter DV, White S, Lavery GG, Tomlinson JW, Sinclair AJ, Odermatt A. Identification of a human blood biomarker of pharmacological 11beta-hydroxysteroid dehydrogenase 1 inhibition. Br J Pharmacol. 2024 Mar;181(5):698-711. doi: 10.1111/bph.16251. Epub 2023 Oct 19.
PubMed 37740611
Grech O, Seneviratne SY, Alimajstorovic Z, Yiangou A, Mitchell JL, Smith TB, Mollan SP, Lavery GG, Ludwig C, Sinclair AJ. Nuclear Magnetic Resonance Spectroscopy Metabolomics in Idiopathic Intracranial Hypertension to Identify Markers of Disease and Headache. Neurology. 2022 Oct 17;99(16):e1702-e1714. doi: 10.1212/WNL.0000000000201007.
PubMed 36240084
Hardy RS, Botfield H, Markey K, Mitchell JL, Alimajstorovic Z, Westgate CSJ, Sagmeister M, Fairclough RJ, Ottridge RS, Yiangou A, Storbeck KH, Taylor AE, Gilligan LC, Arlt W, Stewart PM, Tomlinson JW, Mollan SP, Lavery GG, Sinclair AJ. 11betaHSD1 Inhibition with AZD4017 Improves Lipid Profiles and Lean Muscle Mass in Idiopathic Intracranial Hypertension. J Clin Endocrinol Metab. 2021 Jan 1;106(1):174-187. doi: 10.1210/clinem/dgaa766.
PubMed 33098644
Markey KA, Ottridge R, Mitchell JL, Rick C, Woolley R, Ives N, Nightingale P, Sinclair AJ. Assessing the Efficacy and Safety of an 11beta-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 18;6(9):e181. doi: 10.2196/resprot.7806.
PubMed 28923789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lowering Intracranial Pressure in Idiopathic Intracranial Hypertension: Assessing the Therapeutic Efficacy and Safety of an 11β-hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017). Phase II Study.
ClinicalTrials.gov ID: NCT02017444
Acronym / sponsor ID: IIH:DT / RG_13-022
Conditions: Idiopathic Intracranial Hypertension
Keywords: Pseudotumor Cerebri, Benign Intracranial Hypertension, Headaches, Tinnitus, Papilledema, Blindness, Optic Disk, Intracranial Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of BirminghamUniversity, hospital or other
Study start: 25 Apr 2014 (actual)
Primary completion: 19 Dec 2016 (actual)
Study completion: 19 Dec 2016 (actual)
First posted: 20 Dec 2013 (estimated)
Results: Posted 27 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboMatched placebo tablet B.D for 12 weeks
AZD4017 (11b-HSD1 inhibitor)	Active comparator	Drug: AZD4017AZD4017 400mg tablet B.D. for 12 weeks

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

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:
Patients must be willing to use one form of highly effective non-hormonal contraception. This would include:
Participants are able to continue other medications to treat their IIH e.g. acetazolamide, diuretics but this dose must remain fixed throughout the study.

Key exclusion criteria (29 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD4017Also: 11b-Hydroxysteroid dehydrogenase type 1 inhibitor	Drug	AZD4017 (11b-HSD1 inhibitor)
PlaceboMatched placebo (matched to AZD4017 arm)	Other	Placebo

Primary outcome

Intracranial Pressure
Time frame: 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

14 secondary outcomes

Tinnitus
Time frame: 12 weeks
Anthropometric Measurements (BMI)
Time frame: 12 weeks
Visual Loss
Time frame: 12 weeks
Diplopia
Time frame: 12 weeks
Visual Obscuration
Time frame: 12 weeks
Headache
Time frame: 12 weeks
Visual Acuity
Time frame: 12 weeks
Papilloedema
Time frame: 12 weeks
Headache-associated Disability
Time frame: 12 weeks
Adverse Events
Time frame: 16 weeks
Serious Adverse Events
Time frame: 16 weeks
OCT Total Average Retinal Nerve Fibre Layer Thickness (μm)
Time frame: 12 weeks
Visual Field Mean Deviation
Time frame: 12 weeks
Log Contrast Sensitivity
Time frame: 12 weeks

Results and safety

Results posted to the registry on 27 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	14	12
AZD4017 (11b-HSD1 Inhibitor)	17	17

Primary outcome: Intracranial Pressure

Time frame: 12 weeks. Mean (Standard Deviation). Unit: cmCSF

Measure	Placebo n = 12	AZD4017 (11b-HSD1 Inhibitor) n = 16
Value	-0.3 (5.9)	-4.3 (5.7)

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 14 (7.1%)	11 of 14 (78.6%)	0 of 14
AZD4017 (11b-HSD1 Inhibitor)	0 of 17 (0%)	16 of 17 (94.1%)	0 of 17

Limitations and caveats (from the sponsor): A duration of 12 weeks was chosen for the evaluation of safety and tolerability, being the longest duration of dosing to date with AZD4017. This may not have been enough for meaningful evaluation of clinical outcomes. The sample size is small, which may have reduced power and limited meaningful evaluation of clinical measures: the trial was not designed to establish significant changes in the secondary clinical outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37740611Gomez C, Alimajstorovic Z, Othonos N, Winter DV, White S, Lavery GG, Tomlinson JW, Sinclair AJ, Odermatt A. Identification of a human blood biomarker of pharmacological 11beta-hydroxysteroid dehydrogenase 1 inhibition. Br J Pharmacol. 2024 Mar;181(5):698-711. doi: 10.1111/bph.16251. Epub 2023 Oct 19.
Derived from this study: PubMed 36240084Grech O, Seneviratne SY, Alimajstorovic Z, Yiangou A, Mitchell JL, Smith TB, Mollan SP, Lavery GG, Ludwig C, Sinclair AJ. Nuclear Magnetic Resonance Spectroscopy Metabolomics in Idiopathic Intracranial Hypertension to Identify Markers of Disease and Headache. Neurology. 2022 Oct 17;99(16):e1702-e1714. doi: 10.1212/WNL.0000000000201007.
Derived from this study: PubMed 33098644Hardy RS, Botfield H, Markey K, Mitchell JL, Alimajstorovic Z, Westgate CSJ, Sagmeister M, Fairclough RJ, Ottridge RS, Yiangou A, Storbeck KH, Taylor AE, Gilligan LC, Arlt W, Stewart PM, Tomlinson JW, Mollan SP, Lavery GG, Sinclair AJ. 11betaHSD1 Inhibition with AZD4017 Improves Lipid Profiles and Lean Muscle Mass in Idiopathic Intracranial Hypertension. J Clin Endocrinol Metab. 2021 Jan 1;106(1):174-187. doi: 10.1210/clinem/dgaa766.
Derived from this study: PubMed 28923789Markey KA, Ottridge R, Mitchell JL, Rick C, Woolley R, Ives N, Nightingale P, Sinclair AJ. Assessing the Efficacy and Safety of an 11beta-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 18;6(9):e181. doi: 10.2196/resprot.7806.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexandra Sinclair, MbChb PhD principal investigator

University of Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD4017 in people with Idiopathic Intracranial Hypertension, run by University of Birmingham at 1 site in United Kingdom.

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 15 inclusion and 29 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 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.

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 27 Oct 2021). 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?

Intracranial Pressure (time frame: 12 weeks). 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 NCT02017444, which also lists 4 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 27 Oct 2021.