Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

Exclusion Criteria

• •Subject has confirmed or suspected ischemic heart disease, Prinzmetal's angina, or signs/symptoms consistent with any of the above.
• •Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion contraindicates participation in this study.
• •Subject has a history of congenital heart disease.
• •Subject has a history of cerebrovascular pathology including stroke.
• •The subject, in the investigator's opinion, is likely to have unrecognized cardiovascular disease.
• •Subject has evidence or history of ischemic abdominal syndromes or peripheral vascular disease.
• •Subject has uncontrolled hypertension at screening.
• •Subject has a history of epilepsy or structural brain lesions which lowers the convulsive threshold.
• •Subject has a history of impaired hepatic or renal function.
• •Subject is currently taking a monoamine oxidase inhibitor (MAO) or has taken a MAOI within the 2 weeks prior to screen
• •Subject is currently taking an ergotamine-containing or ergot-type cluster headache preventive medication like ergotamine tartrate or methylergonovine.
• •Subject has hypersensitivity or contraindication to the use of sumatriptan, any of its components, or any other 5-HT1B1D receptor agonist.
• •Subject is pregnant, actively trying to become pregnant or breast-feeding
• •Subject is of childbearing potential and not using adequate contraceptive measures.
• •Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results.
• •Subject has any concurrent medical or psychiatric condition that, in the investigator's opinion, may affect the interpretation of efficacy and safety date or which otherwise contraindicates participation in a clinical trial.
• •Subject has participated in an investigational drug trial within the previous four weeks.
• •Subject is unable or unwilling to self administer subcutaneously administered Imitrex.