Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

Idiopathic Intracranial Hypertension Clinical Trial

Official title:

An Exploratory Study Assessing the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361823
• Other study ID #: IIH-Semaglutide
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Capital Medical University
• Contact: Xunming Ji, MD PhD
• Phone: +86-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Drug:
• Semaglutide
Giving Semaglutide via subcutaneous injections on a weekly basis for a duration of 3 months. The dosage is 0.25 mg for the initial month, then upped to 0.5 mg for patients who could handle it in the second month, and eventually escalated to 1.0 mg for patients who continued to tolerate it in the third month.

Dietary Supplement:
• Low calorie diet
Low calorie diet (max 1200 kcal/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure	The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position.	12 weeks
Primary	Adverse reactions	Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema).	12 weeks
Secondary	Headache severity	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.	Baseline + 12 weeks
Secondary	Degree of papilledema	It is represented by the Frisén Grade (0-5, 0 is the minimal, 5 is the worst) measured by fundoscope.	Baseline + 12 weeks
Secondary	Perimetric mean deviation	It is measured by Humphrey automated perimetry.	Baseline + 12 weeks
Secondary	Optic nerve sheath diameter	It is measured by optic nerve sheath ultrasound.	Baseline + 12 weeks
Secondary	Body mass index	Change in body mass index.	Baseline + 12 weeks