Clinical trial NCT03282227: A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Official title: A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: migraine
migraine headache
acute migraine
acute migraine headache
Lead sponsor: Zosano Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single dose, open-label treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: Main 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.

Main 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

Primary outcomes:
measure: Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
measure: Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
measure: Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
measure: Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
measure: Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
measure: Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose
timeFrame: 2 hours for each Migraine, up to 12 months for each subject
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Jose
country: United States
facility: Allergy Asthma Associates of Santa Clara Valley Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Denver
country: United States
facility: Colorado Allergy Asthma Centers
state: Colorado
city: Hialeah
country: United States
facility: Harmony Medical Research Institute
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache and Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Medical Group PMG Research
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Anderson
country: United States
facility: Primary Care Associates/Radiant Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Neurology Clinic
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
Study officials:
affiliation: Zosano Pharma Corporation
name: Don Kellerman, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: 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.