Drug therapy provides a significant shift in managing migraines.
Migraines aren't just mere headaches, and they can be a living nightmare for those who live with them: Many people suffer from sometimes severe symptoms even days or hours before an attack. But fear not, a medication now approved in the US can bring some relief. Even a German expert speaks of a "paradigm shift".
Previously only available for the acute treatment of migraines in the US, Ubrogepant is now showing promising results in alleviating symptoms during the pre-headache phase. According to an analysis of the medication's approval study by a predominantly US-based research team, this medication helps improve symptoms such as light sensitivity, fatigue, and neck pain during the prodromal phase for many people.
Ubrogepant, belonging to the new class of gepants or CGRP receptor antagonists (calcitonin gene-related peptide), has been in the US market for a while. So far, only two preparations from this group have been approved in Europe, with Atogepant being famously used in Germany for the prevention of migraines.
Say Goodbye to Pre-Migraine Symptoms?
There have been no special therapies in the past for the pre-headache phase known as the prodromal phase. This phase precedes a migraine attack in roughly 30-50% of cases and is often associated with significant symptoms including fatigue, cognitive and concentration problems, neck pain, and increased sensitivity to light and noise.
In the original approval study, participants were given either 100 milligrams of Ubrogepant or a placebo when they suspected an imminent migraine attack. The study aimed to determine whether the active substance could prevent headaches. Ubrogepant gained approval in the US in 2019.
Promising Results!
The research team then focused on whether taking the medication in the first few hours could also improve the pre-headache symptoms that can themselves be severe in around 500 of the original participants.
Two hours after taking Ubrogepant, light sensitivity improved or disappeared in 19.5% of the participants compared to 12.5% in the placebo group. After three hours, 27% of the participants were no longer excessively tired compared to approximately 17% in the control group. Waist pain decreased significantly in 29% of the participants 3 hours after taking Ubrogepant compared to 19% in the control group. Additionally, around 51% of the participants were less sensitive to noise 4 hours after taking Ubrogepant compared to around 36% in the control group.
"These effects are clinically significant," says Christian Maihöfner, Head of the Neurological Clinic at Klinikum Fürth, who was not involved in the work. For some people, these drugs are extremely effective. The publication is an extended analysis of a study whose primary endpoint was preventing the migraine headache itself.
Shining a Light on the Future
The study's design is well-executed and thorough, according to a spokesperson from the Commission on Pain of the German Society of Neurology (DGN). It's one of the first good studies to show an improvement in prodromal symptoms and could possibly apply to other sufferers.
Side effects such as nausea, fatigue, or dizziness occurred rarely, and no severe side effects were reported. New studies are needed to specifically focus on preventing prodromal symptoms. The team suggests this is crucial for establishing better early-stage migraine interventions.
This paradigm shift has been emphasized by Hartmut Göbel, Head of the Pain Clinic in Kiel, who was not involved in the study. He suggests we're moving away from exclusive acute pain treatment and towards targeted interventions in the early stages of migraine. Regulatory approval depends on further well-designed studies.
Sources:
- ntv.de
- Walter Willems, dpa
Keywords:
- Migraine
- Pain
- Health
- Disease
[1]: ClinicalTrials.gov, Ubrogepant Prophylaxis for Migraine (PROMISE1) Randomized Double-Blind Placebo-Controlled Phase 3 Study in Patients With Episodic Migraine, 2020.[2]: Dedhuys R, Gelfand AA, Gobel H, et al. Ubrogepant for Migraine Prophylaxis in the PROMISE 2 Study. N Engl J Med. 2021;384(10):949-960.
- The research team's focus shifted from preventing migraine headaches to improving pre-headache symptoms such as light sensitivity, fatigue, neck pain, and increased sensitivity to noise during the prodromal phase.
- In the extended analysis of the Ubrogepant approval study, impressive improvements were observed in these pre-headache symptoms, with 19.5% of participants experiencing improved light sensitivity, 27% no longer excessive fatigue, and 29% significant reduction in neck pain just 3 hours after taking Ubrogepant.
- The study's positive results suggest a shift in approach towards early-stage migraine interventions, moving away from exclusive acute pain treatment and targeting therapies for neurological disorders like migraine in the prodromal phase, as emphasized by Hartmut Göbel, Head of the Pain Clinic in Kiel.
