None listed
Conditions
Brief summary
Idiopathic intracranial hypertension (IIH) is a rare condition that predominantly affects women aged 16 to 45 years where high pressure inside the skull, known as intracranial pressure (ICP), which causes headaches, and in some cases, can lead to permanent vision loss. Medications to lower ICP are recommended as part of treatment, but currently there are no medication approved for this condition. This pilot study will test whether sodium glucose transport protein 2 inhibitors could lower ICP in women with IIH.
Interventions
Empagliflozin 25mg daily for 12 weeks administered as an oral tablet.
Adherence will be monitored based on drug tablet return.
Sponsors
Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women aged 18 years or older Diagnosis of IIH by consensus criteria Bilateral papilloedema Lumbar puncture opening greater than or equal to 25cm cerebrospinal fluid (CSF) at diagnosis New diagnosis of IIH (screening commenced no more than 8 weeks after diagnostic LP) Body mass index 27-58 kg/m2 Women of childbearing potential must have a negative pregnancy test and must agree to use a highly effective contraception method for the duration of the study Able to provide written informed consent
Exclusion criteria
Medical treatment to lower ICP within 1 week prior to screening Prior surgical treatment to lower ICP Use of drugs known to affect ICP Bariatric surgery Contraindication to SGLT2i use (e.g. Type 1 diabetes) Pregnancy or positive urine dipstick pregnancy test Breastfeeding
Outcome results
None listed