Migraine prevention drug trial in kids halted early

NCT ID NCT04050293

First seen Nov 21, 2025 · Last updated Jun 23, 2026 · Updated 22 times

Summary

This study tested a drug called SPN-538 to prevent migraines in children aged 6 to 11. The trial was a randomized, double-blind, placebo-controlled study, meaning some children got the drug and some got a placebo. However, the study was terminated early and only enrolled 26 participants, so we cannot draw firm conclusions about its effectiveness or safety.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • CNS Healthcare

    Memphis, Tennessee, 38119, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

SPN-538 (a drug to prevent migraines)

What this could lead to

If it worked, this could offer a new option to reduce migraine frequency in young children.

What could go wrong

The trial was terminated early with very few participants, so results are limited and may not be reliable. It is unclear if SPN-538 is safe or effective for this age group.

Conditions

The condition(s) this trial relates to.

headache disorder migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.