Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06027567
Eligibility Criteria:
Inclusion Criteria:
* Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria
* BMI ≥ 27
* Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide
* Written, informed consent
Exclusion Criteria:
* Unable to provide written informed consent or participate
* Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
* Pregnancy or breastfeeding
* Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
* Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy)
* History or family history of thyroid carcinomas or Multiple Endocrine Neoplasias (MEN1/MEN2)
* History of bariatric surgery
* Known hypersensitivity to any contents of Semaglutide®
* Other severe/uncontrolled mental or physical disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06027567
Study Brief:
Protocol Section:
NCT06027567