An Exploratory Study Assessing the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 主要终点
- Intracranial pressure
研究概览
简要总结
This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.
详细描述
Idiopathic intracranial hypertension (IIH) is a condition characterized by elevated pressure within the skull for reasons that are not yet understood. This condition does not involve abnormalities in the cerebrospinal fluid or any structural brain damage. Individuals with this condition commonly experience persistent headaches, and some may face the potential of irreversible vision loss, significantly impacting their psychological well-being and overall quality of life. At present, the efficacy of medications like acetazolamide and topiramate in managing IIH is constrained by practical clinical constraints. Recent studies have indicated that glucagon-like peptide-1 receptor agonists show promise as a potential treatment option for IIH. Semaglutide, as a long-acting glucagon-like peptide-1 formulation, has a half-life of up to 160 hours and only needs to be injected once a week. It is easy to administer and has good safety and tolerability. Hence, the objective of this study is to investigate the effectiveness and safety of semaglutide in managing idiopathic intracranial hypertension, laying the groundwork for subsequent extensive, multicenter research endeavors.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 75 years old, both male and female.
- •Confirmed definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria.
- •Voluntarily sign a written informed consent form.
排除标准
- •Pregnant or breastfeeding women.
- •Currently using any hypoglycemic drugs, including glucagon like peptide-1 receptor agonists.
- •Known to be allergic to the active ingredients or any excipients in Semaglutide.
- •History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasias (MEN1/MEN2).
- •Diabetes, ketoacidosis, severe gastrointestinal diseases, pancreatitis, severe heart failure.
- •Vision loss caused by other diseases, such as diabetes retinopathy, iritis, cataract, etc.
- •Malignant IIH with vision at risk necessitating surgical intervention.
- •Unable to cooperate in completing imaging examinations.
- •History of bariatric surgery or cerebrospinal fluid diversion.
- •Have used any drugs known to increase intracranial pressure within the past 3 months (including vitamin A, tetracycline drugs, lithium, etc).
- •Have participated in other clinical trials within the past 3 months, or did not withdraw from other clinical trials at the time of signing the informed consent form.
- •Other situations determined by the researcher that may pose a threat to the patients' life safety or may have an impact on the study.
研究组 & 干预措施
Semaglutide
Expanding on the usual treatment regimen, Semaglutide is administered through a subcutaneous injection once weekly over a period of 3 months. Initially, the dose is 0.25 mg for the first month, then increased to 0.5 mg for patients who could tolerate it in the second month, and finally raised to 1.0 mg for patients who still tolerated it in the third month.
干预措施: Semaglutide (Drug)
Semaglutide
Expanding on the usual treatment regimen, Semaglutide is administered through a subcutaneous injection once weekly over a period of 3 months. Initially, the dose is 0.25 mg for the first month, then increased to 0.5 mg for patients who could tolerate it in the second month, and finally raised to 1.0 mg for patients who still tolerated it in the third month.
干预措施: Low calorie diet (Dietary Supplement)
Usual treatment
Usual treatment refers to the 2018 consensus guidelines on the management of IIH.
干预措施: Low calorie diet (Dietary Supplement)
结局指标
主要结局
Intracranial pressure
时间窗: 12 weeks
The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position.
Adverse reactions
时间窗: 12 weeks
Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema).
次要结局
- Headache severity(Baseline + 12 weeks)
- Degree of papilledema(Baseline + 12 weeks)
- Perimetric mean deviation(Baseline + 12 weeks)
- Optic nerve sheath diameter(Baseline + 12 weeks)
- Body mass index(Baseline + 12 weeks)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University