- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745392
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine (Zotrip)
Randomized, Double-blind, Multi-center, Parallel-group, Dose-ranging Comparison of the Safety and Efficacy of the ZP-Zolmitriptan Intracutaneous Microneedle Systems to Placebo for the Acute Treatment of Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Glendale, Arizona, United States, 85306
- Clinical Research Advantage, Inc./Thunderbird Internal Medicine
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California
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Carlsbad, California, United States, 92011
- The Research Center of Southern California
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Huntington Beach, California, United States, 92647
- Allergy and Asthma Specialists Medical Group and research Center
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Los Angeles, California, United States, 90017
- Downtown LA Research Center
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Mission Viejo, California, United States, 92691
- Allergy & Asthma Associates of Southern California
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San Jose, California, United States, 95117
- Allergy and Asthma Associates of Santa Clara Valley Research Center
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Santa Monica, California, United States, 90404
- California Medical Clinic for Headache
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Upland, California, United States, 91786
- Empire Clinical Research
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Colorado
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Denver, Colorado, United States, 80230
- Colorado Allergy & AsthmaCenters, PC
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Connecticut
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Stamford, Connecticut, United States, 06905
- Ki Health Partners
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Florida
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DeLand, Florida, United States, 32720
- Avail Clinical Research, LLC
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Orange City, Florida, United States, 32763
- Medical Research Group of Central Florida
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Tampa, Florida, United States, 33634
- Meridien Research
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Georgia
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Boston Clinical Trials
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New Bedford, Massachusetts, United States, 02740
- Novex Medical Research
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North Dartmouth, Massachusetts, United States, 02714
- Northeast Medical Research Associates, Inc.
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Watertown, Massachusetts, United States, 02472
- MedVadis Research Corporation
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Michigan Head Pain &Neurological Institute
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Kalamazoo, Michigan, United States, 49009
- Westside Family Medical Center, P.C
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Minnesota
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Minneapolis, Minnesota, United States, 55402
- Clinical Research Institute, Inc.
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Missouri
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Saint Louis, Missouri, United States, 63141
- The Clinical Research Center, LLC
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Springfield, Missouri, United States, 65807
- Clinvest/A Division of Banyan Group Inc.
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Nebraska
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Bellevue, Nebraska, United States, 68123
- Nebraska Medical Research Institute
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Skillman, New Jersey, United States, 08558
- Princeton Center for Clinical Research
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North Carolina
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Greensboro, North Carolina, United States, 27405
- Headache Wellness Center, PC
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High Point, North Carolina, United States, 27262
- Peters Medical Research LLC
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Raleigh, North Carolina, United States, 27607
- North Carolina Clinical Research
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Raleigh, North Carolina, United States, 27609
- PMG Research of Raleigh
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Ohio
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Cincinnati, Ohio, United States, 45227
- CTI Clinical Research Center
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Nashville Neurosciences Group
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Texas
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New Braunfels, Texas, United States, 78130
- Central Texas Health Research
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San Antonio, Texas, United States, 78229
- Sylvana Research Associates
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Virginia
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Charlottesville, Virginia, United States, 22911-3568
- Charlottesville Medical Research Center LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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:
- An average of at least two qualifying migraines per 28-day period
- No more than 10 headache days in the last 28 days prior to randomization
- Demonstrated ability to properly use the eDiary and apply the demo study drug patch
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ZP-Zolmitriptan 1 mg
ZP-Zolmitriptan 1 mg patch single administration
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ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
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Experimental: ZP-Zolmitriptan 1.9 mg
ZP-Zolmitriptan 1.9 mg patch single administration
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ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
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Experimental: ZP-Zolmitriptan 3.8 mg
ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration
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ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
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Placebo Comparator: Placebo
Placebo (either single or double patch) single administration
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Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With Pain Freedom
Time Frame: 2 hours
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Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints.
Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose.
Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours.
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2 hours
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Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)
Time Frame: 2 hours
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The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint.
This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.
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2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Donald Kellerman, Pharm.D., Zosano Pharma Corporation
Publications and helpful links
General Publications
- Tepper SJ, Dodick DW, Schmidt PC, Kellerman DJ. Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult-to-Treat Migraine Headaches. Headache. 2019 Apr;59(4):509-517. doi: 10.1111/head.13482. Epub 2019 Jan 30.
- Spierings EL, Brandes JL, Kudrow DB, Weintraub J, Schmidt PC, Kellerman DJ, Tepper SJ. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia. 2018 Feb;38(2):215-224. doi: 10.1177/0333102417737765. Epub 2017 Oct 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Zolmitriptan
Other Study ID Numbers
- CP-2016-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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