Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache
Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the effects of sodium oxybate on headache response
(frequency), sleep quality and quality of life in the prophylactic treatment of patients with
chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g
in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night
until treatment Response will be evaluated in an interventional, placebo-controlled,
double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of
nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective
level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free
episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S,
CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).