Status:
ACTIVE_NOT_RECRUITING
The Effect of an Anti-obesity Drug, Semaglutide, As Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (dietician) with Regards to Change in Weight and Intracranial Pressure
Lead Sponsor:
Rigmor Højland Jensen
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Idiopathic Intracranial Hypertension
Intracranial Pressure
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
50 patients with verified new-onset Idiopathic Intracranial Hypertension are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous i...
Detailed Description
Idiopathic Intracranial Hypertension is primarily observed in obese female and weight management promotes disease control by yet unsettled mechanisms. Effective, fast and lasting weight loss is crucia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06027567
Start Date
September 2 2022
End Date
October 30 2025
Last Update
January 6 2025
Active Locations (2)
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1
Headache clinic, Department of Neurology, Odense University Hospital
Odense, Odense, Denmark, 5000
2
Danish Headache Center, Department of Neurology, Rigshospitalet
Glostrup Municipality, Denmark, 2600