Plain-English translation of NCT05711394 on ClinicalTrials.gov ↗ ·
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether , a medication already approved for adults with migraines, is safe and effective for children and teenagers ages 6 to 17. works by preventing migraines before they start, taken as a daily tablet. The trial will compare two different doses of the medication against a placebo (inactive pill) to find out which works best for kids.
While doctors have several migraine treatments for adults, there are very few approved options for children and teenagers. This trial aims to fill that gap by testing whether this medication can help young people prevent migraines and improve their quality of life.
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Participants will visit a clinic or hospital regularly over 12 weeks to take a daily tablet (either the medication or placebo) and have their migraines tracked. Younger children (ages 6–11) may first participate in a brief dosage-finding phase to determine the right dose for their age group. At the end of 12 weeks, participants can choose to stop with a final follow-up visit or continue in an extended study for up to one more year.
AI-generated summary from trial data · Jun 29, 2026 · Not medical advice
United States