Ongoing Clinical Trials for Idiopathic Intracranial Hypertension
Two clinical trials are currently investigating new approaches for idiopathic intracranial hypertension. One study examines advanced imaging techniques using a contrast agent to better understand cerebrospinal fluid flow, while another explores the combination of medication and dietary intervention for weight management and pressure reduction. (Also known as: IIH, Pseudotumor Cerebri, Benign Intracranial Hypertension)
Clinical trial locations
- Denmark
- Norway
Study of Gadobutrol for MRI in Adults with Cerebrospinal Fluid Disorders, Including Hydrocephalus and Brain Tumors
This trial, conducted in Norway, focuses on improving our understanding of cerebrospinal fluid movement in the brain using advanced imaging techniques. The study involves several conditions related to brain and spinal fluid, including idiopathic intracranial hypertension.
Main focus: The trial aims to visualize how fluids flow and clear within the brain by using magnetic resonance imaging (MRI) enhanced with a special contrast agent called gadobutrol. This imaging technique helps doctors identify where blockages in cerebrospinal fluid flow might exist and how quickly substances are removed from the brain and surrounding fluid. The primary goal is to observe time-dependent changes in signal intensity on brain MRI scans after the contrast agent is administered.
Investigational drug: The study uses an intrathecal contrast agent, gadobutrol, which is a gadolinium-based compound. This agent is injected directly into the spinal canal, where it mixes with cerebrospinal fluid. This allows for enhanced visualization on MRI scans, helping doctors better assess fluid dynamics in the brain.
Who can participate: The trial is open to both males and females, ranging from children to adults. Participants must have one of several conditions, including idiopathic intracranial hypertension, communicating hydrocephalus, idiopathic intracranial hypotension, intracranial cysts, primary malignant brain tumors, or a history of subarachnoid hemorrhage. Participants should not belong to a vulnerable population.
Who cannot participate: The exclusion criteria appear to overlap with the inclusion criteria in the source data, which may indicate that specific subtypes or severity levels of these conditions are being carefully selected. Patients should discuss their specific situation with the research team to determine eligibility.
Study on Semaglutide and Low-Calorie Diet for Weight Loss in Patients with New-Onset Idiopathic Intracranial Hypertension
This Danish trial explores a treatment approach that combines medication with dietary intervention to manage newly diagnosed idiopathic intracranial hypertension. The condition is characterized by increased pressure around the brain without a clear cause, and it commonly affects overweight women.
Main focus: The study investigates whether combining Semaglutide medication with a very low-calorie diet can help reduce body weight and lower brain pressure in patients with new-onset disease. Researchers will monitor changes in intracranial pressure, body weight, optic nerve swelling, visual function, headache patterns, and overall quality of life over a period of 10 months. The trial compares this combined approach to standard dietary management.
Investigational drug: Semaglutide is the medication being tested in this trial. It works by mimicking a natural hormone called GLP-1 that helps regulate appetite and makes people feel fuller, leading to reduced food intake and weight loss. The medication is administered as a once-weekly injection under the skin. Different doses are being studied, including those available under the brand names Ozempic and Wegovy.
Who can participate: This trial is specifically for females aged 18 to 65 years who have been newly diagnosed with idiopathic intracranial hypertension. Participants must have swelling of the optic nerve and a lumbar opening pressure of at least 25 cm of cerebrospinal fluid. A Body Mass Index of 27 or higher is required. Women of childbearing potential must use highly effective contraception during the study and for two months after stopping the medication. Participants must provide written informed consent.
Who cannot participate: Males cannot participate in this study. Patients outside the specified age range, those without the specific diagnosis, and individuals from vulnerable populations are excluded from the trial.
Summary
Two distinct clinical trials are currently underway for idiopathic intracranial hypertension, each taking a different approach to understanding and managing this condition. The Norwegian study focuses on diagnostic imaging to better understand fluid dynamics in the brain, while the Danish trial takes a therapeutic approach by combining medication and dietary intervention to address the condition through weight loss and pressure reduction.
Notably, the Danish trial specifically targets female patients with new-onset disease and obesity, reflecting the epidemiological pattern of this condition, which predominantly affects overweight women. The emphasis on weight management through Semaglutide and dietary intervention acknowledges the important relationship between body weight and intracranial pressure in this condition.
Both trials are geographically concentrated in Scandinavian countries, suggesting strong research interest in this region. The Norwegian imaging study takes a broader diagnostic approach, including idiopathic intracranial hypertension alongside several other cerebrospinal fluid disorders, while the Danish study focuses exclusively on this condition. Together, these trials represent both improved diagnostic capabilities and novel therapeutic strategies for managing idiopathic intracranial hypertension.
