Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks

Summary

The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache. It is an 16 week, randomized, double-blind, placebo- controlled, bi-center trial. LXB will be administered as a twice nightly regimen. All subjects will undergo an 6 week Treatment Titration and Optimization Phase. The main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.

Timeline

Start

2026-01

Primary completion

2027-12

Completion

2028-05

Publications

• van Liefland M, van Tilborg PJ, Szmukala M, Zhang Z, Kramers C, Lammers GJ, Khatami R, Fronczek R. Efficacy, safety, and tolerability of low sodium oxybate for nocturnal cluster headache attacks in chronic cluster headache: protocol for a phase II randomized, double-blind, placebo-controlled, trial (SUNCET). Pain Manag. 2026 Jul;16(7):703-711. doi: 10.1080/17581869.2026.2660895. Epub 2026 Apr 20.

Drugs

Indications