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
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.