Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertens… (NCT06361823) | Clinical Trial Compass
UnknownPhase 3
Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
74 participantsStarted 2024-05-01
Plain-language summary
This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.