A new injectable peptide-based drug, normally used to treat type-2 diabetes, could treat IIH headaches.
A trial conducted by the University of Birmingham has found that the drug, exenatide, could be used to treat patients who suffer from Idiopathic Intracranial Hypertension (IIH) or ‘blinding headaches’.
In the trial, seven patients received regular injections of exenatide, which is a GLP-1 receptor agonist. The study showed the drug led to drops in both short (2.5-24 hours) and long-term (24 hours) brain pressure measurements.
The study, titled ‘The effect of GLP-1RA exenatide on idiopathic intracranial hypertension: a randomized clinical trial,’ was published in Brain.
What are IIH headaches?
IIH headaches are caused by increased pressure in the brain, and the condition can be debilitating, leading to chronic pain and permanent loss of sight. IIH, which can be caused by weight gain, predominately affects women between the ages of 26 and 36.
IIH was once considered a rare disease, but rates of the condition have risen dramatically in recent years, alongside a 350% global increase in obesity over the last ten years. There are currently approved drug options for IIH headaches, and the condition is often treated with off-label medicines with problematic side effects.
The researchers also found considerable reductions in the number of headaches across the 12-week trial. On average, participants reported 7.7 fewer days of headaches per month compared to the baseline; members placed in a placebo subgroup only reported a reduction of 1.5 fewer days of headaches.
“This is a major trial for the rare and debilitating condition IIH that can lead to people, usually women, going blind and suffering disabling daily headaches. There are no current licenced drugs to treat IIH, and hence this result is a major step forward for IIH patients,” said Alex Sinclair, Professor of Neurology at the Institute of Metabolism and Systems Research at the University of Birmingham.
“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 eight 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 from IIH headaches,” continued Sinclair.
The treatment works with remarkable speed
The researchers found that exenatide worked rapidly, and brain pressure was significantly reduced within two and a half hours of administering the medicine. The fast onset of the drug is vital as IIH headaches can cause rapid blindness if treatment is delayed.
“The results of this clinical trial are a shot in the arm for 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. This treatment may prove relevant for other conditions resulting in raised brain pressure,” said Dr James Mitchell, Lecturer in Neurology at the University of Birmingham.
“This is such exciting progress. New drug options are vitally important for IIH headaches, 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 III clinical trials,” concluded Shelly Williamson, Chair of patient charity IIH UK.