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

February 13, 2018 updated by: Zosano Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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. Subjects who have consented and meet the entry criteria will be randomized to one of four blinded treatment groups. There will be a screening period of up to 1 week, followed by a run-in period to record migraine activity. The run-in period is to determine eligibility for randomization, and is planned to be 4 weeks in duration but may be extended up to an additional 4 weeks to accommodate scheduling. Qualified subjects will randomize to the double-blind treatment period at Day 0 and will have up to 8 weeks to confirm and treat a qualifying migraine. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patch or patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Glendale, Arizona, United States, 85306
        • Clinical Research Advantage, Inc./Thunderbird Internal Medicine
    • California
      • Carlsbad, California, United States, 92011
        • The Research Center of Southern California
      • Huntington Beach, California, United States, 92647
        • Allergy and Asthma Specialists Medical Group and research Center
      • Los Angeles, California, United States, 90017
        • Downtown LA Research Center
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates of Santa Clara Valley Research Center
      • Santa Monica, California, United States, 90404
        • California Medical Clinic for Headache
      • Upland, California, United States, 91786
        • Empire Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Colorado Allergy & AsthmaCenters, PC
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Health Partners
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Tampa, Florida, United States, 33634
        • Meridien Research
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • New Bedford, Massachusetts, United States, 02740
        • Novex Medical Research
      • North Dartmouth, Massachusetts, United States, 02714
        • Northeast Medical Research Associates, Inc.
      • Watertown, Massachusetts, United States, 02472
        • MedVadis Research Corporation
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain &Neurological Institute
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center, P.C
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
      • Springfield, Missouri, United States, 65807
        • Clinvest/A Division of Banyan Group Inc.
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Nebraska Medical Research Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center, PC
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research LLC
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • CTI Clinical Research Center
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Neurosciences Group
    • Texas
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research Associates
    • Virginia
      • Charlottesville, Virginia, United States, 22911-3568
        • Charlottesville Medical Research Center LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

    1. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
    2. 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:

    1. ischemic changes
    2. Q-waves in at least two contiguous leads,
    3. clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome), or
    4. 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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: ZP-Zolmitriptan 1 mg
ZP-Zolmitriptan 1 mg patch single administration
ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Experimental: ZP-Zolmitriptan 1.9 mg
ZP-Zolmitriptan 1.9 mg patch single administration
ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Experimental: ZP-Zolmitriptan 3.8 mg
ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration
ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Placebo Comparator: Placebo
Placebo (either single or double patch) single administration
Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Pain Freedom
Time Frame: 2 hours
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.
2 hours
Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)
Time Frame: 2 hours
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Donald Kellerman, Pharm.D., Zosano Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

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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