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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acute Migraine

In brief

This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo.

Key facts

Study ID

NCT02745392

Run by

Zosano Pharma Corporation

People needed

365

Starts

2016-06-01

Expected to finish

2017-01-01

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than 1 year history of episodic, acute migraine (with or without aura) with onset prior to 50 years of age. Diagnosis must comply with International Headache Society (IHS) diagnostic criteria. Diagnostic criteria must include a history of at least five attacks not attributed to any other disorder that include all of the following criteria:
• Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
• Headache has at least two of the following characteristics:
• (i) unilateral location (ii) pulsating quality (iii) moderate or severe pain intensity (iv) aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) c) During headache at least one of the following: (i) nausea and/or vomiting (ii) both photophobia and phonophobia
• Migraine history during the 6-month period prior to the run-in period must include: 2-8 migraines per month and no more than 10 headache days per month
• Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy during the trial, and must use an acceptable methods of birth control for the duration of the trial.
• No significant ECG findings, defined by:
• ischemic changes
• Q-waves in at least two contiguous leads,
• clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome), or
• clinically significant arrhythmias (e.g., current atrial fibrillation)
• Able to understand the operation of the electronic diary and is able to apply the demo study drug patch.

You may not qualify if…

• 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

Where it is running

• Clinical Research Advantage, Inc./Thunderbird Internal Medicine — Glendale, Arizona, United States
• The Research Center of Southern California — Carlsbad, California, United States
• Allergy and Asthma Specialists Medical Group and Research Center — Huntington Beach, California, United States
• Downtown LA Research Center — Los Angeles, California, United States
• Allergy & Asthma Associates of Southern California — Mission Viejo, California, United States
• Allergy and Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Empire Clinical Research — Upland, California, United States
• Colorado Allergy & AsthmaCenters, PC — Denver, Colorado, United States
• Ki Health Partners — Stamford, Connecticut, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Novex Medical Research — New Bedford, Massachusetts, United States
• Northeast Medical Research Associates, Inc. — North Dartmouth, Massachusetts, United States
• MedVadis Research Corporation — Watertown, Massachusetts, United States
• Michigan Head Pain &Neurological Institute — Ann Arbor, Michigan, United States
• Westside Family Medical Center, P.C — Kalamazoo, Michigan, United States
• Clinical Research Institute, Inc. — Minneapolis, Minnesota, United States
• Clinvest/A Division of Banyan Group Inc. — Springfield, Missouri, United States
• The Clinical Research Center, LLC — St Louis, Missouri, United States
• Nebraska Medical Research Institute — Bellevue, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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