Table 2.

Inclusion and Exclusion Criteria

Inclusion Criteria

Is male or female, in otherwise good health, 18-80 years of age. Has history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment. Has onset of migraine before age 50 years. Is able to differentiate migraine from any other headache they may experience (eg, tension-type headache). Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period. If female of childbearing potential, agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator. Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug; or, Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or, Sterilization of male partner; or, Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or, Double barrier method (ie, 2 physical barriers or one physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or, Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.

Exclusion Criteria

Has nasal septal deformity such as cleft lip and palate, choanal atresia, atropic rhinitis, rhinitis medicamentosa. Has septal perforation. Has had recent nasal/midface trauma (<3 months). Has nasal or facial fracture. Has had recent nasal/sinus surgery (<3 months). Has a bleeding disorder such as Von Willebrand disease or hemophilia. Has severe respiratory distress. Has neoplasm such as angiofibroma, sinus tumor, granuloma. Has had nasal congestion present more than 10 days with fever (temperature ≥ 100.4 F) and nasal mucous is an abnormal color. Uses drug substances inhaled through the nasal system that, in the opinion of the investigator, would confound the results of the study. Is currently treating migraine using a prescription for a Schedule II narcotic. Is a current cocaine user. Has skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding. Has recurrent nosebleeds. Has allergy to bupivacaine. Is known to be pregnant, actively trying to become pregnant, or breastfeeding. Has concurrent cervicogenic headache or occipital neuralgia as defined by ICHD criteria. Has severe clinical depression or severe anxiety that, in the opinion of the investigator, may interfere with study participation. Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol, or is unwilling to complete headache records or continue participation in the study. Has received any investigational agents within 30 days prior to visit 1. Plans to participate in another clinical study at any time during this study.

ICHD = International Classification of Headache Disorders, second edition.