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).

Abstract

BACKGROUND: Cluster headache presents with severe headache attacks that typically occur during sleep. This study aims to evaluate the efficacy, tolerability, and safety of low sodium oxybate (LXB), a sleep-deepening drug, for nocturnal attacks in chronic cluster headache. METHOD: In this randomized, double-blind, placebo-controlled, bi-center trial, we will include 52 participants (18-75 years) with chronic cluster headache and ≥4 nocturnal attacks per week. Participants with a contraindication for LXB will be excluded. After a 4-week baseline phase, participants will be randomized to receive either LXB or placebo as a twice nightly regimen during the treatment phase. All participants will undergo a 6-week titration phase followed by a 4-week stable dose treatment phase. The primary outcome is the change from baseline in the average weekly frequency of nocturnal cluster headache attacks during the 4-week stable dose treatment phase, comparing the LXB group to the placebo group. Secondary and exploratory outcomes include change in daytime attack frequency, the improvement of sleep quality and sleep continuity parameters. DISCUSSION: The results of this trial could have a substantial impact on the treatment for chronic cluster headache, particularly for patients suffering from frequent nocturnal attacks. CLINICAL TRIAL REGISTRATION: The www.clinicaltrials.gov identifier is NCT06950281.