A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine

NCT ID: NCT03282227

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2019-05-17

Brief Summary

This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the electronic diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the eDiary post treatment administration.

Detailed Description

This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period (14 to 21 days) to determine eligibility for treatment with study medication based on daily eDiary data collection. Qualified subjects will receive study medication on Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be treated with a single dose, consisting of two patches, but subjects can treat multiple migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

M207 Microneedle System 3.8 mg

M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)

Group Type: EXPERIMENTAL

M207 Microneedle System

Intervention Type: DRUG

M207 Microneedle System 3.8 mg

Interventions

M207 Microneedle System

M207 Microneedle System 3.8 mg

Intervention Type: DRUG

Other Intervention Names

ZP-Zolmitriptan Intracutaneous Microneedle System; ADAM-Zolmitriptan

Eligibility Criteria

Inclusion Criteria

1. Women or men 18 to 75 years of age

2. Greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age.

3. Migraine history during the prior 6 months must include:

1. at least 2 migraines per month

2. no more than 8 migraines per month

3. no more than 15 headache days per month

4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial.

5. Willing and able to treat a minimum of 2 migraines per month with study medication and consistently complete eDiary for up to 12 months.

Exclusion Criteria

1. Contraindication to triptans

2. Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs like Coumadin®)

3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations

4. Known allergy or sensitivity to adhesives and/or titanium

5. Women who are pregnant, breast-feeding or plan a pregnancy during this study

6. Three or more of the following cardiovascular risk factors:

• Current tobacco use
• Hypertension or receiving anti-hypertensive medication for hypertension
• Hyperlipidemia or on prescribed anti-cholesterol treatment
• Family history of premature coronary artery disease
• Diabetes mellitus

7. History or current abuse or dependence on alcohol or drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zosano Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don Kellerman, Pharm.D.

Role: STUDY_DIRECTOR

Zosano Pharma Corporation

Locations

Achieve Clinical Research

Birmingham, Alabama, United States

Elite Clinical Studies

Phoenix, Arizona, United States

Downtown L.A. Research Center

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Allergy 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 Asthma Centers

Denver, Colorado, United States

Harmony Medical Research Institute

Hialeah, Florida, United States

Advanced Clinical Research

Meridian, Idaho, United States

DelRicht Research

New Orleans, Louisiana, United States

Boston Clinical Trials

Boston, Massachusetts, United States

MedVadis Research Corporation

Watertown, Massachusetts, United States

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

Clinical Research Institute

Plymouth, Minnesota, United States

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Clinvest Research

Springfield, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Rochester Clinical Research

Rochester, New York, United States

Peters Medical Research

High Point, North Carolina, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Raleigh Medical Group PMG Research

Raleigh, North Carolina, United States

Lillestol Research

Fargo, North Dakota, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Primary Care Associates/Radiant Research

Anderson, South Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

University of Texas Southwestern Medical Center - Neurology Clinic

Dallas, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Countries

United States

References

Nahas SJ, Hindiyeh N, Friedman DI, Elbuluk N, Kellerman DJ, Foreman PK, Schmidt P. Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine. J Headache Pain. 2021 May 17;22(1):37. doi: 10.1186/s10194-021-01249-z.

Reference Type: DERIVED

PMID: 34001002 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CP-2017-001

Identifier Type: -

Identifier Source: org_study_id