Clinical Trial

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

Study acronym: SUNCET
Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-24.
Trial Details
NCT Number NCT06950281
Lead Sponsor Leiden University Medical Center
Conditions Chronic Cluster Headache
Enrollment 52 participants
Start Date 2026-01
Primary Completion 2027-12 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-24