A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
ADAM
A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
1 other identifier
interventional
342
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2017
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2019
CompletedResults Posted
Study results publicly available
August 19, 2020
CompletedAugust 19, 2020
August 1, 2020
1.5 years
September 5, 2017
July 20, 2020
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.
0 to 12 months
Secondary Outcomes (6)
Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose
2 hours for each Migraine, up to 12 months for each subject
Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose
2 hours for each Migraine, up to 12 months for each subject
Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose
2 hours for each Migraine, up to 12 months for each subject
Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose
2 hours for each Migraine, up to 12 months for each subject
Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose
2 hours for each Migraine, up to 12 months for each subject
- +1 more secondary outcomes
Study Arms (1)
M207 Microneedle System 3.8 mg
EXPERIMENTALM207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Interventions
M207 Microneedle System 3.8 mg
Eligibility Criteria
You may qualify if:
- Women or men 18 to 75 years of age
- Greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age.
- Migraine history during the prior 6 months must include:
- at least 2 migraines per month
- no more than 8 migraines per month
- no more than 15 headache days per month
- 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.
- Willing and able to treat a minimum of 2 migraines per month with study medication and consistently complete eDiary for up to 12 months.
You may not qualify if:
- Contraindication to triptans
- Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs like Coumadin®)
- Known allergy or sensitivity to zolmitriptan or its derivatives or formulations
- Known allergy or sensitivity to adhesives and/or titanium
- Women who are pregnant, breast-feeding or plan a pregnancy during this study
- 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
- History or current abuse or dependence on alcohol or drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Downtown L.A. Research Center
Los Angeles, California, 90017, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Allergy Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Empire Clinical Research
Upland, California, 91786, United States
Colorado Allergy Asthma Centers
Denver, Colorado, 80230, United States
Harmony Medical Research Institute
Hialeah, Florida, 33016, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303-3041, United States
Clinvest Research
Springfield, Missouri, 65810, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Raleigh Medical Group PMG Research
Raleigh, North Carolina, 27609, United States
Lillestol Research
Fargo, North Dakota, 58103, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Primary Care Associates/Radiant Research
Anderson, South Carolina, 29621, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
University of Texas Southwestern Medical Center - Neurology Clinic
Dallas, Texas, 75390, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Related Publications (1)
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.
PMID: 34001002DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Donald Kellerman, PharmD, Sr. VP, Clin Dev and Med Affairs
- Organization
- Zosano Pharma Corporation
Study Officials
- STUDY DIRECTOR
Don Kellerman, Pharm.D.
Zosano Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open-label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 13, 2017
Study Start
November 7, 2017
Primary Completion
May 17, 2019
Study Completion
May 17, 2019
Last Updated
August 19, 2020
Results First Posted
August 19, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share