Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine

Inclusion criteria

• Subject has a diagnosis of migraine headache, with or without aura
• Subject and subject's parent or legal guardian are able to read and write English
• Subject must have a negative drug screen.
• Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of acceptable contraception
• Subject has one acceptable patch application site (left or right upper arm or thigh) that is relatively hair free and has no scars, tattoos, or abrasions
• Subject must have a body mass index of between the 5th and 84th percentile for age and sex
• Subject must be nonsmokers
• Subject must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission to the clinic

• Additional criteria apply, please contact the investigator for more information

Exclusion criteria

• Subject has suspected or confirmed cardiovascular disease
• Subject has a history of epilepsy or conditions associated with a lowered seizure threshold
• Subject with Raynaud's disease
• Subject has a history of basilar or hemiplegic migraines
• Subject has a current diagnosis of a major depressive disorder
• Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitors(SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs, including Wellbutrin), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) or preparations containing St. John's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study and through the End of Study visit
• Subject with a history of a significant allergy or hypersensitivity to any component of the study patch used in this study
• Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis
• Subject is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• Female subjects who are pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception
• Subject has known history of tolerability issues with sumatriptan
• Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence
• Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study within 30 days of last study visit
• Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device).

• Additional criteria apply, please contact the investigator for more information