What the trial was testing
The HOPE enrolled 237 patients with migraine. The study was sponsored by H. Lundbeck A/S and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People getting the higher dose had 2 fewer migraine days per month than those on placebo.
The New England journal of medicine · 2024 · NCT05133323
These findings — that compared to placebo over 4 weeks with the 750-mg dose — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 237 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with migraine, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and Lu AG09222 is not yet FDA-approved for migraine. If you have hard-to-treat migraine, talk to your doctor about currently approved CGRP antibodies or other preventive options, and ask whether there are open trials testing this new PACAP-targeting approach.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open migraine trials
Tai Chi for the Prophylaxis of Episodic Migraine: the Efficacy Examination and Mechanism Exploration
The proposed study aims to examine the clinical efficacy of 24-week Tai Chi training in the prophylaxis of episodic migraine comparing with standard prophylactic medication in Hong Kong Chinese women, and to explore the mechanism of Tai Chi's intervention effect by examining the associations of changes in migraine features with neurovascular and neuroinflammation variations.
Treatment of Meniere's Disease With Migraine Medications
Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.