Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

Inclusion criteria

• ✓. Current diagnosis of cluster headache according to the criteria of International Headache Classification (ICHD-II, 2005) of the International Headache Society (IHS).
• ✓. Diagnosis of cluster headache has been made at least 6 weeks after start of screening
• ✓. Patients will have nocturnal pain attacks
• ✓. Duration since onset of current cluster episode at least 1 week
• ✓. Patients will have at least 1 attack per 48 hours and at least 4 attacks cumulatively by the time of visit 2 (prior to randomization)
• ✓. Disturbed sleep quality
• ✓. Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
• ✓. Women must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control. Patients should agree to continue this method for the duration of the study and for one month after the discontinuation of SO treatment. Women should be negative to serum pregnancy test performed at the screening visit. Females should not be breastfeeding patient.

Exclusion criteria