Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

Multicenter study to test the safety and efficacy of sodium oxybate in the prophylaxis of headache and sleep disturbances in patients with chronic and episodic cluster headache using a placebo-controlled, double blind, randomized study, parallel group design. Patients with predominant nocturnal attacks and poor sleep quality will be evaluated; At least 1 attack every other day and at least 8 attacks cumulatively by the time prior to randomization are required. Sodium oxybate will be orally administered, 3-9g per night, starting with 3g in two nightly dosages of 1.5g (the first at bedtime and the second 4 hours later). Dosage will be gradually increased by steps of 1.5g every second night until treatment response during a titration period of 14 days. Effects od sodium oxybate will be monitored via pain and sleep diaries during a 14 days stable treatment phase by reviewing sleep/pain diaries and Quality of life assessement. Primary outcomes are frequency of nocturnal pain attacks; Main secondary outcomes are frequency, intensity and duration of daytime pain attacks, improvement of sleep quality, quality of life, duration and rates of pain free episodes, decrease in escape medication for acute headache attacks (use of triptans). Safety parameters are ECG, laboratory, depressions scales, vital signs, respiratory polygraphy. Intent-to treat analysis, multivariate analysis of variance (MANOVA) with depending variable (reduction of pain frequency and pain intensity of nocturnal attacks) and the co-variates (age, sex , chronic vs. episodic CH).