This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months
Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months
Duke University Medical Center
Durham, North Carolina, United States
Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.
Time frame: From enrollment to end of treatment at 12 months
Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT)
Mean change in RNFL thickness
Time frame: From enrollment to end of treatment at 12 months
Change in Frisen papilledema grade on fundus photography
The Frisen scale ranges from 0 (normal optic disc) to 5 (severe degree of edema).
Time frame: From enrollment to the end of treatment at 12 months
Change in perimetric mean deviation
Perimetric Mean Deviation (MD) is a key visual field index that represents the average point-by-point difference between a patient's visual field and the normal, age-matched expected visual field.
Time frame: From enrollment to end of treatment at 12 months
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