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 intravenous —a medication traditionally used for anesthesia—can help reduce severe, long-lasting headaches that occur 15 or more days per month. Half of the participants will receive the medication through an IV infusion, while the other half will receive saline (salt water) as a comparison. Researchers want to know if is both safe and more effective than placebo for people living with chronic daily headaches.
Chronic daily headaches are debilitating and hard to treat with current medications—many people don't get relief even after trying multiple treatments. Early research suggests this treatment might help reduce headache frequency and severity, which is why researchers want to test it carefully in a larger group of patients.
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If you join this study, you will be randomly assigned to receive either a infusion or a placebo (saline) infusion through an IV. You'll spend about 6 hours at Toronto Western Hospital's pain infusion unit, where an anesthesiologist will monitor your vital signs and keep you gently sedated throughout the procedure. You will receive medications to prevent nausea and blood clots, and the research team—as well as you—won't know which treatment you received, so that results are as fair as possible.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
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