Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

Exclusion criteria

• . The use of sodium oxybate or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial.
• . Change of prophylactic treatment 2 weeks prior of baseline visit 1
• . Have sleep apnea syndrome, defined as an Apnea index \> 10 per hour or an Apnea-hypopnea Index (AHI) \> 15/h or an oxygen desaturation index (ODI) \> 15/h
• . Are taking hypnotics, tranquilizers, antihistamines (except for medication as defined in section 9.4.1. "authorized medication"), benzodiazepines at the start of the baseline period.
• . Patients with psychiatric and neurological disorders, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical depression (BDI ≥ 16 with suicidal risk: item G BDI \>0).
• . Patients who are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
• . Patients who are unable or unwilling to temporarily discontinue any unauthorized drugs or substances, in particular refrain from alcohol (see section non-authorized treatments).
• . Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).