Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- Dietary Supplement: Low calorie diet
- Registration Number
- NCT06361823
- Lead Sponsor
- Capital Medical University
- Brief Summary
This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 74
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual treatment Low calorie diet Usual treatment refers to the 2018 consensus guidelines on the management of IIH. Semaglutide Low calorie diet 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. Semaglutide 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.
- Primary Outcome Measures
Name Time Method Intracranial pressure 12 weeks The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position.
Adverse reactions 12 weeks Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema).
- Secondary Outcome Measures
Name Time Method Body mass index Baseline + 12 weeks Change in body mass index.
Headache severity Baseline + 12 weeks It is measured by the questionnaire "Headache Impact Test-6" (HIT-6); score range is 36-78. The higher the score, the more severe the headache.
Degree of papilledema Baseline + 12 weeks It is represented by the Frisén Grade (0-5, 0 is the minimal, 5 is the worst) measured by fundoscope.
Perimetric mean deviation Baseline + 12 weeks It is measured by Humphrey automated perimetry.
Optic nerve sheath diameter Baseline + 12 weeks It is measured by optic nerve sheath ultrasound.