A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Placebo
Participants receive Tirzepatide Placebo weekly on the following dose schedule for a year:
Dosage Treatment time 2.5mg/0.5mL: Month 1 (4 Weeks) 5mg/0.5mL: Month 2 (4 Weeks) 7.5mg/0.5mL: Month 3 (4 Weeks) 10mg/0.5mL: Month 4 (4 Weeks) 12.5mg/0.5mL: Month 5-6 15mg/0.5 mL: Month 7-12
干预措施: Tirzepatide Placebo (Drug)
Tirzepatide
Participants receive Tirzepatide weekly on the following dose schedule for a year:
Dosage Treatment time 2.5mg/0.5mL: Month 1 (4 Weeks) 5mg/0.5mL: Month 2 (4 Weeks) 7.5mg/0.5mL: Month 3 (4 Weeks) 10mg/0.5mL: Month 4 (4 Weeks) 12.5mg/0.5mL: Month 5-6 15mg/0.5 mL: Month 7-12
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
时间窗: From enrollment to end of treatment at 12 months
Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.
次要结局
- Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT)(From enrollment to end of treatment at 12 months)
- Change in Frisen papilledema grade on fundus photography(From enrollment to the end of treatment at 12 months)
- Change in perimetric mean deviation(From enrollment to end of treatment at 12 months)