Tirzepatide in Idiopathic Intracranial Hypertension Trial

Inclusion criteria

• Signs and symptoms of increased intracranial pressure:

• headaches, tinnitus, visual obscurations, papilledema;
• absence of localizing findings on neurological examination (except for VI nerve palsy);
• no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;
• elevated lumbar puncture (LP) opening pressure (OP) ≥25 cm H2O in lateral decubitus position with legs extended (>= (≥ 20cm H2O if one of the following is present: pulse synchronous tinnitus, abducens palsy, Frisen grade II papilledema, transverse venous sinus stenosis, partially empty sella or enlarged optic nerve sheath on magnetic resonance imaging (MRI);
• the patient is awake and alert.
• BMI ≥30 kg/m2
• Age 18-60 years of age
• Unilateral or bilateral papilledema
• Able to provide informed consent
• Women of child-bearing age must use birth control (non-oral contraceptive method or add a barrier method of contraception).

Exclusion criteria

• Previous bariatric surgery
• Prior intervention for high ICP including optic nerve sheath fenestration (ONSF), venous stenting and/or shunting
• Taking another GLP-1 agonist, another drug that can interfere with the GLP-1 agonist, or any other anti-obesity medication
• History of pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), history of gallbladder disease, ulcerative colitis, Crohn's disease, or history of hypersensitivity reaction in response to the drug
• Pregnancy or planning a pregnancy in the next 12 months or currently breastfeeding
• Other disorders causing visual loss and/or anomalous optic nerve
• Taking another medication to lower ICP in IIH (if previously taking another medication for ICP must be off this medication for at least 30 days prior to enrollment)
• No change in headache medications in the past 60 days
• Venous sinus thrombosis on magnetic resonance venography (MRV)
• Papilledema Frisen Grade III, IV or fulminant IIH
• Mean perimetric deviation ≤ -7 dB
• CSF contents outside of normal limits
• Uncontrolled hypertension (≥140mmHg/90 mmHg)
• Anemia (hemoglobin [Hgb] ≤ 8.0g/dL)
• Diagnosed sleep apnea with continuous positive airway pressure (CPAP) use
• Exposure to a drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines
• eGFR < 30 ml/min/1.73m2
• Type II diabetes