Low Sodium Oxybate as a Treatment for Nocturnal Cluster Headache

Low sodium oxybate (LXB) will be administered as a twice nightly regimen. All subjects will undergo an 8 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 with equal appearance