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Acute MigrainePhase 2/3ZotripNCT02745392

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

A Phase 2/3 study testing ZP-Zolmitriptan in people with Acute Migraine, run by Zosano Pharma Corporation at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Migraine
What is being tested?
ZP-Zolmitriptan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
365 participants
Where
36 sitesUnited States
Study dates
Jun 2016to Jan 2017
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 32Show fewer
  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Michigan Head Pain &Neurological Institute

    Ann Arbor, Michigan, 48104

  • Nebraska Medical Research Institute

    Bellevue, Nebraska, 68123

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • Charlottesville Medical Research Center LLC

    Charlottesville, Virginia, 22911-3568

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Colorado Allergy & AsthmaCenters, PC

    Denver, Colorado, 80230

  • Clinical Research Advantage, Inc./Thunderbird Internal Medicine

    Glendale, Arizona, 85306

  • Headache Wellness Center, PC

    Greensboro, North Carolina, 27405

  • Peters Medical Research LLC

    High Point, North Carolina, 27262

  • Allergy and Asthma Specialists Medical Group and Research Center

    Huntington Beach, California, 92647

  • Westside Family Medical Center, P.C

    Kalamazoo, Michigan, 49009

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Downtown LA Research Center

    Los Angeles, California, 90017

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Allergy & Asthma Associates of Southern California

    Mission Viejo, California, 92691

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Nashville Neurosciences Group

    Nashville, Tennessee, 37203

  • Novex Medical Research

    New Bedford, Massachusetts, 02740

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Northeast Medical Research Associates, Inc.

    North Dartmouth, Massachusetts, 02714

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • Clinvest/A Division of Banyan Group Inc.

    Springfield, Missouri, 65807

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Ki Health Partners

    Stamford, Connecticut, 06905

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33634

  • Empire Clinical Research

    Upland, California, 91786

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Acute Migraine
Being tested
ZP-Zolmitriptan, Placebo
Keywords
migraine, migraine headache, acute migraine, acute migraine headache
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZP-ZolmitriptanDrug

    ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

  • PlaceboDrug

    Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

Study groups in NCT02745392
Study groupRoleWhat they receive
ZP-Zolmitriptan 1 mgExperimentalZP-Zolmitriptan 1 mg patch single administration
Receives: Drug: ZP-Zolmitriptan
ZP-Zolmitriptan 1.9 mgExperimentalZP-Zolmitriptan 1.9 mg patch single administration
Receives: Drug: ZP-Zolmitriptan
ZP-Zolmitriptan 3.8 mgExperimentalZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration
Receives: Drug: ZP-Zolmitriptan
PlaceboPlacebo comparatorPlacebo (either single or double patch) single administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects With Pain Freedom

    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.

    Measured: 2 hours

  2. Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)

    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.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02745392
Sponsor's protocol ID
CP-2016-001
Acronym
Zotrip
Status last verified
Feb 2018
First submitted
14 Apr 2016
Last updated
13 Mar 2018
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 30698272

  • 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.

    PubMed 29022755

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ZP-Zolmitriptan in people with Acute Migraine, run by Zosano Pharma Corporation at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Pain Freedom (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02745392, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.

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