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 a 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.
None
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.
Parallel
Low Sodium Oxybate
DrugLow sodium oxybate (LXB) will be administered as a twice nightly regimen. All subjects will undergo an 6 week Treatment Titration and Optimization Phase. Titration should proceed in an increment of 1.5g per night each 7 days until a 50% reduction in nocturnal headache frequency is achieved or a maximum dose (9g per night) is reached. If a subject is unable to titrate to a higher dose, they may stay at the highest tolerated dose for the duration of the study. Subjects may stop titration or have dose reduction at any time for safety and tolerability reasons.
Placebo
DrugPlacebo with equal appearance
Change in average weekly frequency of nocturnal cluster headache attacks (verum vs placebo)
During 4-week fixed stable dose treatment phase compared to baseline. Nocturnal attacks are defined as attacks occurring between the time a participant goes to bed and the time they get out of bed, with a minimum window of 8 hours after bedtime. (verum vs placebo)
Change in percentage of participants with a ≥30% reduction in the weekly number of nocturnal Cluster Headache Attacks
At week during 4-week fixed stable dose treatment phase compared to baseline.
Change in percentage of participants with a ≥50% reduction in the weekly number of nocturnal Cluster Headache Attacks
During 4-week fixed stable dose treatment phase compared to baseline.
Change in weekly frequency of cluster headache attacks in a 24-hr period during
During a 4-week fixed stable dose treatment phase compared to baseline.
Change in percentage of participants with a ≥30% reduction in the weekly number of cluster headache attacks in a 24-hr period (daytime and nocturnal attacks)
During 4-week fixed stable dose treatment phase compared to baseline.
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