Clinical trial NCT06361823: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
Official title: An Exploratory Study Assessing the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Idiopathic Intracranial Hypertension
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intracranial pressure
timeFrame: 12 weeks
measure: Adverse reactions
timeFrame: 12 weeks
Secondary outcomes:
measure: Headache severity
timeFrame: Baseline + 12 weeks
measure: Degree of papilledema
timeFrame: Baseline + 12 weeks
measure: Perimetric mean deviation
timeFrame: Baseline + 12 weeks
measure: Optic nerve sheath diameter
timeFrame: Baseline + 12 weeks
measure: Body mass index
timeFrame: Baseline + 12 weeks
Other outcomes:
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