New dosing options for xywav could help fight daytime sleepiness

NCT ID NCT07625280

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tests whether expanded dosing regimens of Xywav can safely reduce excessive daytime sleepiness in adults with narcolepsy or idiopathic hypersomnia. About 108 participants will receive either Xywav or a placebo in a randomized withdrawal design. The main goal is to see if sleepiness scores improve on the Epworth Sleepiness Scale.

What this could mean

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

Active substance
Xywav (calcium, magnesium, potassium, and sodium oxybates solution)
What this could lead to
If successful, this could offer more flexible dosing options for Xywav to better control daytime sleepiness in people with narcolepsy or idiopathic hypersomnia.
What could go wrong
This is a relatively small Phase 3 trial (108 participants) and uses a randomized withdrawal design, so results may not apply to everyone. Xywav can cause side effects like dizziness, nausea, and sleepwalking.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Intrepid Research

    Cincinnati, Ohio, 45245, United States

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