A new study has found that people with ‘blinding’ migraines known as Idiopathic Intracranial Hypertension (IIH) may benefit from an injectable peptide used to treat type 2 diabetes. The study, which was published recently in the journal Brain, describes a phase two trial of exenatide, a GLP-1 receptor agonist, as a possible therapy for IIH.
The IIH Pressure Trial, led by a team of neurologists from the University of Birmingham and University Hospitals Birmingham, discovered that regular injections of the drug, which is currently approved for use in Type 2 Diabetes, resulted in a drop in brain pressure during both short (2.5 hours and 24 hours) and long term (12 weeks) measurements.
The experiment also found substantial decreases in the number of headaches over the course of 12 weeks, with an average of 7.7 fewer headache days per month when compared to the baseline, compared to only 1.5 fewer days in the combination group.
Alex Sinclair a Professor of Neurology at the University of Birmingham’s Centre of Metabolism and Systems Research said, “This is a big study for the uncommon and devastating disorder IIH, which can cause patients to go blind and suffer from crippling daily headaches. There are currently no licenced medications to treat IIH, therefore this outcome is a significant step forward for IIH sufferers.”
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 expect to see a much larger trial with exenatide to physically relieve the strain on the many people suffering from IIH throughout the world.”
Idiopathic intracranial hypertension (IIH) is a severe disorder that causes increased pressure in the brain, resulting in chronic headaches and potentially irreversible vision loss. The ailment, which frequently reduces patients’ quality of life, specifically targets women aged 25 to 36, and weight increase is a key risk factor for having IIH and relapsing the disease.
Long thought to be rare, the prevalence of IIH is now growing drastically in tandem with the global rise in obesity, with a 350 per cent increase in incidence in the previous ten years. There are currently no licenced drugs available, and existing pharmaceuticals used off-label are compounded by problematic side effects.
The quick impact of the medicine was a noteworthy finding, with studies revealing that brain pressure dramatically decreased within two and a half hours after taking the prescription. It is the early beginning of action critical in a disease that, if left untreated, can result in rapid blindness.
Dr James Mitchell, Lecturer in Neurology at the University of Birmingham and the paper’s initial author stated, “The outcomes of this clinical research represent a shot in the arm for identifying therapeutic therapies for IIH. While more trials are needed before such a treatment could be made available to patients, we are motivated by the significant results from this trial, which made a real difference for those in the treatment arm, and this diagnosis may prove relevant for other conditions resulting in elevated brain pressure.”
In this study, the drug was given 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 trialled through the University of Birmingham Start-up company, Invex Therapeutics.
This is a fantastic improvement. Novel treatment choices are critical for IIH, and this trial gives hope to the millions of individuals who suffer from the disorder. We eagerly await the following phases and the drug’s testing in two big Phase 3 clinical studies”, said Shelly Williamson, the Chair of patient charity IIH UK.
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