Evidence map›Paper›PMID 28923789›Full record

ArticleJMIR research protocols2017

Assessing the Efficacy and Safety of an 11β-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.

Keira Annie Markey, Ryan Ottridge, James L Mitchell, Caroline Rick, Rebecca Woolley, Natalie Ives, Peter Nightingale, Alexandra J Sinclair

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02017444 (Lowering Intracranial Pressure in Idiopathic Intracranial Hypertension), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02017444 phase2completednot on this map

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.

TypeinterventionalSponsorUniversity of BirminghamRan2014 to 2016Enrolled31ConditionsIdiopathic Intracranial HypertensionArmsAZD4017, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Keira Annie Markey *Neurometabolism, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0001-9396-7330
Ryan OttridgeBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0002-8685-2145
James L MitchellNeurometabolism, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0001-6785-9352
Caroline RickBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0001-7713-9834
Rebecca WoolleyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0001-5119-1431
Natalie IvesBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0002-1664-7541
Peter NightingaleInstitute of Translational Medicine, Queen Elizabeth Hospital, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0001-7194-3557
Alexandra J SinclairNeurometabolism, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.ORCID http://orcid.org/0000-0003-2777-5132
Cancer Research UK Clinical Trials Unit · GBQueen Elizabeth Hospital Birmingham · GBThe Edgbaston Hospital · GB

Funding

Department of Health NIHR-CS-011-028Medical Research Council MR/K015184/1Wellcome Trust
6 · The paper itself

Abstract

backgroundIdiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH.

objectivesThe purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology.

methodsIIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H

resultsAll participants were recruited between April 2014 and August 2016.

conclusionsIIH:DT is the first phase II double-blind randomized placebo-controlled trial assessing the efficacy and safety of the novel pharmacological intervention, AZD4017, for the treatment of IIH.

trial registrationClinicaltrials.gov NCT02017444; https://clinicaltrials.gov/ct2/show/NCT02017444 (Archived by WebCite at http://www.webcitation.org/6tVHesN6s).

Indexed as

11beta-HSD1clinical protocolclinical trials, Phase IIidiopathic intracranial hypertensionrandomised controlled trial

Identifiers

PMID28923789
PMCPMC5625129
OpenAlexW2754520134

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.