NCT02017444.

Trial name or 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.
Methods	Double‐blind, parallel assignment RCT
Participants	Female participants between 18 and 55 years. Diagnosis of IIH by the Modified Dandy criteria with: acute (< six months) active disease (papilloedema) raised ICP > 25 cmH2O) normal brain imaging (either magnetic resonance venography or computerised tomography with venography).
Interventions	AZD4017 (11b‐HSD1 inhibitor) 400 mg tablet twice daily for 12 weeks versus matched placebo tablet twice‐daily for 12 weeks
Outcomes	Primary outcome measures: ICP measured by lumbar puncture. Secondary outcome measures: IIH symptoms (presence or absence of tinnitus, visual loss, diplopia, visual obscurations, and headache). Visual function (visual acuity, visual fields and contrast sensitivity). Papilloedema. Anthropological measurements (blood pressure, body mass index, waist/hip ratio, DXA scan). Adverse events. Other outcome measures: AZD4017 assay levels in blood and CSF. Glucocorticoid metabolites. HPA‐associated hormone levels. Fat mass distribution. Fat/skin 11β‐HSD1 activity. Systemic 11β‐HSD1 activity (1st pass metabolism). Adipocyte gene expression. CSF inflammatory markers.
Starting date	January 2014
Contact information	Alexandra Sinclair; a.b.sinclair@bham.ac.uk
Notes	NCT02017444