A new treatment option for a blinding headache also known as Idiopathic Intercranial Hypertension (IIH) appears.
Idiopathic intracranial hypertension (IIH) is a condition characterized by high pressure around the brain, resulting in symptoms such as headaches and vision changes. The term “idiopathic” denotes that the underlying cause of the condition is unknown, “intracranial” refers to the skull, and “hypertension” indicates high pressure.
IIH arises when there is an excess of cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord, accumulating within the skull. This leads to added pressure on the brain and the optic nerve at the back of the eye.
Currently, there are no approved medications available for the treatment of IIH.
Now, a new study says that an injectable peptide, commonly prescribed to individuals suffering from type 2 diabetes, could potentially offer relief to patients experiencing debilitating headaches known as Idiopathic Intercranial Hypertension (IIH) or ‘blinding’ headaches.
Today, the journal Brain has published a report on a phase two trial that explored the efficacy of exenatide, a GLP-1 receptor agonist, as a possible solution for treating IIH.
According to the IIH Pressure Trial, conducted by a group of neurologists from the University of Birmingham and University Hospitals Birmingham, administering regular injections of exenatide to seven patients led to a decrease in brain pressure during short (2.5 hours and 24 hours) and long-term (12 weeks) evaluations.
This drug is currently approved for treating Type 2 Diabetes.
During the trial, participants experienced a significant decrease in the frequency of headaches over the 12-week period, with an average of 7.7 fewer headache days per month compared to baseline. In contrast, the placebo group saw only 1.5 fewer headache days per month.
Alex Sinclair, the Principal Investigator of the study and Professor of Neurology at the Institute of Metabolism and Systems Research at the University of Birmingham, as well as an Honorary Consultant Neurologist at University Hospitals Birmingham NHS Foundation Trust, has led the research team.
Professor Alex Sinclair expressed the significance of the trial’s outcomes for individuals struggling with IIH, a rare and debilitating condition that primarily affects women and can lead to blindness and disabling headaches.
“There are no current licenced drugs to treat IIH and hence this result is a major step forward for IIH patients.
“We are delighted to see that the phase two trial resulted in our treatment group having lower brain pressure both immediately and after 12 weeks and nearly 8 fewer headache days across the 12-week period, and that all the women were able to continue the treatment throughout with few adverse effects.
“We now hope to see a much larger trial of exenatide to literally ease the pressure for the many people around the world suffering with IIH.”
Idiopathic Intracranial Hypertension (IIH) is a distressing ailment that elevates the pressure in the brain, resulting in chronic headaches and, in some cases, permanent vision loss. The disease primarily affects women between the ages of 25 and 36, and weight gain is a significant risk factor for developing IIH and experiencing disease relapses. Patients living with IIH often experience a decreased quality of life due to the condition’s debilitating nature.
Previously considered a rare condition, the incidence of IIH has increased dramatically in recent years, consistent with the global rise in obesity. Over the last decade, there has been a 350% increase in IIH incidence. Currently, there are no approved drug options for treating IIH, and using existing medications off-label is complicated by troublesome side effects.
One of the study’s significant findings was the quick action of the medication, with results showing a significant reduction in brain pressure within two and a half hours of taking the drug. This rapid onset of action is crucial in treating a condition that can lead to rapid blindness if left untreated.
Dr. James Mitchell, a Neurology Lecturer at the University of Birmingham and the lead author of the paper, expressed his enthusiasm for the clinical trial’s results, which may provide a much-needed boost in finding clinical treatments for IIH.
“While we need to do further trials before such a treatment could be available for patients in the future, we are encouraged by the significant results from this trial that made a real difference for those in the treatment arm and this treatment may prove relevant for other conditions resulting in raised brain pressure.”
In this study, the drug was administered as a twice-daily injection into the subcutaneous tissue. To reduce the need for frequent injections in the future, a once-weekly subcutaneous injection called Presendin will be trialed through Invex Therapeutics, a University of Birmingham start-up company.
“This is such exciting progress. New drug options are vitally important for IIH and this trial brings hope to the millions of patients living with the condition. We very much look forward to the next steps and seeing the drug tested in two large Phase 3 clinical trials,” comments Shelly Williamson, the Chair of patient charity IIH UK.
The IIH Advance is an international Phase 3 clinical study for adults sponsored by Invex Therapeutics, while IIH Evolve is an international Phase 3 clinical trial for adolescents sponsored by the University of Birmingham. The ultimate goal is to gather enough information to enable the medicine to be approved for future use in IIH patients.
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