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

Inclusion criteria Age ≥18 and ≤75 at the time of consent. Diagnosed with chronic cluster headache according to the International Classification of Headache Disorders (ICHD-III) criteria. Free of other cluster headache prophylactic medication OR on stable dose for at least 4 weeks. Not having received a GON (Greater Occipital Nerve) injection or oral prednisone in the previous 3 months. At least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset during the night between 22:00 and 08:00), not exclusively appearing during a single night, but spread across multiple nights. Exclusion criteria Suspected of having another trigeminal autonomic cephalalgia (TAC). Other headaches if the patient cannot reliably distinguish them from cluster headache attacks. Weight at inclusion of \<50kg or \>120kg. Significant active or unstable psychiatric disease in the opinion of the investigator. Significant pulmonary or neuromuscular diseases in the opinion of the investigator. A history of or current indication of substance abuse or substance use disorder. Unwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm. Stimulator devices which could influence sleep or cluster headache symptoms, such as an occipital nerve stimulator (ONS), when settings have not been stable for at least three months prior to screening. Participation in a clinical trial of an investigation drug or device in the past 30 days. Women who are…