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

NCT02745392 | Completed Phase 2 Results

• 1 other identifier: CP-2016-001
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 36

Brief 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.

Conditions

Acute Migraine

Keywords

migraine; migraine headache; acute migraine; acute migraine headache

Outcome Measures

Primary Outcomes (2)

• 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.

  2 hours

• 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.

  2 hours

Study Arms (4)

ZP-Zolmitriptan 1 mg

EXPERIMENTAL

ZP-Zolmitriptan 1 mg patch single administration

Drug: ZP-Zolmitriptan

ZP-Zolmitriptan 1.9 mg

EXPERIMENTAL

ZP-Zolmitriptan 1.9 mg patch single administration

Drug: ZP-Zolmitriptan

ZP-Zolmitriptan 3.8 mg

EXPERIMENTAL

ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration

Drug: ZP-Zolmitriptan

Placebo

PLACEBO COMPARATOR

Placebo (either single or double patch) single administration

Drug: Placebo

Interventions

ZP-Zolmitriptan DRUG

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

ZP-Zolmitriptan 1 mg; ZP-Zolmitriptan 1.9 mg; ZP-Zolmitriptan 3.8 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Zosano Pharma Corporation: lead

Study Sites (36)

Clinical Research Advantage, Inc./Thunderbird Internal Medicine

Glendale, Arizona, 85306, United States

Location

The Research Center of Southern California

Carlsbad, California, 92011, United States

Location

Allergy and Asthma Specialists Medical Group and Research Center

Huntington Beach, California, 92647, United States

Location

Downtown LA Research Center

Los Angeles, California, 90017, United States

Location

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

Colorado Allergy & AsthmaCenters, PC

Denver, Colorado, 80230, United States

Location

Ki Health Partners

Stamford, Connecticut, 06905, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Novex Medical Research

New Bedford, Massachusetts, 02740, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02714, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

Location

Michigan Head Pain &Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Westside Family Medical Center, P.C

Kalamazoo, Michigan, 49009, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Clinvest/A Division of Banyan Group Inc.

Springfield, Missouri, 65807, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Nebraska Medical Research Institute

Bellevue, Nebraska, 68123, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Headache Wellness Center, PC

Greensboro, North Carolina, 27405, United States

Location

Peters Medical Research LLC

High Point, North Carolina, 27262, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45227, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Nashville Neurosciences Group

Nashville, Tennessee, 37203, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research Center LLC

Charlottesville, Virginia, 22911-3568, United States

Location

Related Publications (2)

• 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.

  PMID: 30698272 DERIVED

• 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.

  PMID: 29022755 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Donald Kellerman
• Organization: Zosano Pharma Corporation

dkellerman@zosanopharma.com

(510) 745-4004

Study Officials

• Donald Kellerman, Pharm.D.

  Zosano Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 20, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 13, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)