Plain-English translation of NCT05125302 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 trial is testing , a medication already approved for treating migraines in adults, to see if it is safe and works well in children and teenagers ages 6–17. The study will involve about 1,059 young people across roughly 120 sites in the United States over up to 6 months. Researchers will compare the medication at different doses against a placebo (a pill with no active ingredient) to find out which dose works best and causes the fewest side effects.
Migraine is very common in children and causes real suffering—with severe headaches, nausea, and sensitivity to light and sound. While this medication is already helping adults, doctors need to know if it is safe and effective for younger patients, and what the right dose should be for different age groups.
You likely qualify if…
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First, younger children (ages 6–11) in the early part of the study will take small amounts of the medication so doctors can figure out the best dose. Then, all children and teens will be randomly assigned to receive either the medication at a low dose, a high dose, or a placebo. When you have a qualifying migraine, you'll take the study medication at home and record how you feel in a diary. You can take a second dose or rescue medication 2 hours later if needed. You'll attend regular clinic visits for about 6 months for check-ups, blood tests, and questionnaires to monitor how you're doing.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
United States