Background STAT-509 is an investigational once-daily oral me…
Background STAT-509 is an investigational once-daily oral medication being developed for the prevention of episodic migraine in adults. Several preventive treatment options are currently available. However, not all patients obtain adequate benefit, and some discontinue treatment because of adverse effects or treatment burden. Phase 2 Study A single-arm Phase 2 study enrolled 40 adults with episodic migraine. Eligible participants experienced between 6 and 12 migraine days per month during a 4-week baseline period. All participants received STAT-509 for 12 weeks. Participants were permitted to use their usual acute medications to treat individual migraine attacks. The primary Phase 2 endpoint was change from baseline in the number of monthly migraine days during the final 4 weeks of treatment. Outcome STAT-509 Number treated 40 Mean monthly migraine days at baseline 8.4 Mean change in monthly migraine days at Week 12 -4.4 Treatment discontinuation 10% Discontinuation due to adverse events 7.5% Nausea 20% Serious adverse events None observed The study also collected a migraine-specific patient-reported measure of daily functioning. Results suggested improvement during treatment, although this outcome was exploratory. Published studies of currently available preventive migraine treatments in broadly similar populations suggest an average reduction of approximately 2.5-3.0 migraine days per month over a similar treatment period. The development team considers the Phase 2 findings promising and is now planning a Phase 3 trial. Proposed Phase 3 clinical research question In adults with episodic migraine, does treatment with STAT-509 reduce monthly migraine days compared with an appropriate control over 24 weeks?
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