Plain-English translation of NCT05306899 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
The KetHead study is testing whether — a medication delivered through an IV — can help people with chronic daily headaches. Researchers will compare this medication to a placebo (a saline solution that looks identical) to see if it actually reduces headache frequency and severity. You would receive the infusion in a medical setting where doctors can monitor your vital signs and keep you comfortable throughout the procedure.
Chronic daily headaches can be very difficult to treat, and many people don't get relief from current medications. Researchers believe this medication might offer a new option for people whose headaches haven't improved with standard treatments.
You likely qualify if…
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If you are selected, you will come to one of two Toronto hospitals for a single infusion appointment. You'll receive sedating medication to keep you relaxed and comfortable, along with anti-nausea medication and other supportive drugs. Then you'll either receive the study medication or a placebo infusion over 6 hours while doctors monitor your heart rate and blood pressure. Researchers and you won't know which group you're in, and they'll follow up with you afterward to see how your headaches respond.
AI-generated summary from trial data · Jun 9, 2026 · Not medical advice
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