Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine

Exclusion Criteria

• •Contraindication to triptans
• •Use of any prohibited concomitant medications within 10 days of the Run-in Period
• •History of hemiplegic or basilar migraine
• •Participation in another investigational trial during the 30 days prior to the Run-in Period or during this study
• •Previous participation in a clinical trial of ZP-Zolmitriptan
• •Diagnosis of cancer (other than non-invasive skin cancer) within the 5 years prior to the Run-in Period
• •History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to the Run-in Period
• •Subjects who have known allergy or sensitivity to zolmitriptan or its derivatives or formulations
• •Subjects who have known allergy or sensitivity to adhesives
• •Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application site from two weeks prior to screening through the last day of study participation
• •Use of opiate analgesics or barbiturates more frequently than one day/week
• •Women who are pregnant, breast-feeding or plan a pregnancy during this study
• •Clinically significant liver disease
• •Clinically significant kidney disease
• •History of coronary artery disease (CAD), coronary vasospasm (including Prinzmetal's angina), aortic aneurysm, peripheral vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome)
• •Three or more of the following CAD risk factors:
• •* Current tobacco use
• •* Hypertension or receiving anti-hypertensive medication for treatment of hypertension
• •* Hyperlipidemia or on prescribed anti-cholesterol treatment
• •* Family history of premature coronary artery disease (\< 55 years of age in male first degree relatives or \< 65 years of age in female first degree relatives)
• •* Diabetes mellitus
• •History of cerebral vascular accident, transient ischemic attacks, or seizures
• •Hospitalization within the 30 days prior to the Run-in Period
• •Any other household member currently participating in a ZP-Zolmitriptan study or relatives of site staff
• •Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible
• •History or current abuse or dependence on alcohol or drugs that would interfere with adherence to study requirements
• •Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the subject at risk
• •To be eligible for Treatment, subjects must continue to meet all eligibility criteria and the following criteria observed during the Run-in Period:
• •1. An average of at least two qualifying migraines per 28-day period
• •2. No more than 10 headache days in the last 28 days prior to randomization
• •3. Demonstrated ability to properly use the eDiary and apply the demo study drug patch
• •4. Confirmation of continuing good general health, or stable non-serious disease that in the opinion of the Investigator will not place the subject at risk.