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.
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Sleep apnoea syndrome or increased apnoea index (AI > 15/h).
High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5).
Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator.
Porphyria.