Assessing the therapeutic efficacy and safety of an 11ß-hydroxysteroid dehydrogenase type 1 inhibitor (AZD4017) in idiopathic intracranial hypertension (IIH). - Efficacy and safety of 11b-HSD1 inhibitor in IIH

niversity of Birmingham0 sites30 target enrollmentDecember 11, 2013

ConditionsIdiopathic Intracranial Hypertension MedDRA version: 18.0Level: PTClassification code 10004277Term: Benign intracranial hypertensionSystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Idiopathic Intracranial Hypertension
Sponsor: niversity of Birmingham
Enrollment: 30
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 11, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

niversity of Birmingham

Eligibility Criteria

Inclusion Criteria

•1\.Provision of informed consent prior to any study specific procedures.
•2\.Female patients between 18 and 55 years old
•3\.Diagnosis of IIH by the updated Modified Dandy criteria with acute (\<6 months from Neuro\-opthalmology diagnosis), active disease (papilloedema (Frisen grade greater than or equal to 1\) and significantly raised intracranial pressure \>25cmH2O) and normal brain imaging during previous routine diagnostic work up (evaluated by either magnetic resonance venography or computerised tomography with venography).
•4\.Patients must be willing to use one form of highly effective, non\-hormonal contraception. This would include a vasectomised partner, tubal occlusion or copper containing IUD – all of which should be used in addition to a barrier contraceptive (condom or diaphragm or cervical/vault caps with spermicidal foam/gel/film/suppository) or 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 b\-hCG blood test at screening and urine testing at all trial visits (including the final follow up visit 4 weeks after discontinuation of study treatment).
•5\. Participants are able to continue other medications to treat their IIH e.g. acetazolamide, diuretics but this dose must remain fixed throughout the study. It would be expected that there would be an equal number in each trial.
•6\.Must be able to understand the consent form and comply with study requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 30

Exclusion Criteria

•1\.Optic nerve sheath fenestration (as distortion of the optic nerve would prevent accurate assessment of their disease state). Patients who have had previous failed CSF shunting will be eligible for enrolment if they fulfil all other enrolment criteria.
•2\.Abnormal neurological examination (aside from papilloedema and consequent visual loss or VI nerve palsy).
•3\.Subjects with a secondary cause of raised intracranial pressure will be excluded.
•4\.Abnormal cerebrospinal fluid contents (except for that compatible with a traumatic LP).
•5\.Unable to perform a visual field test reliably.
•General Exclusion Criteria:
•1\.Positive hCG or urine dipstick pregnancy test or planning to conceive.
•2\.Have eGFR calculated by MDRD equation of \<60ml/min/1\.73m2\.
•3\.Have any endocrine disorder, e.g, thyroid dysfunction (potential participants with PCOS will no be excluded as this is a known associated condition).
•4\.Suspicion of or known Gilbert's disease.