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

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: M207 Microneedle System

• Registration Number: NCT03282227
• Lead Sponsor: Zosano Pharma Corporation

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.

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-11-07
• Primary Completion: 2019-05-17
• Study Completion: 2019-05-17
• Results First Submitted: 2020-07-20
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Results First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months	0 to 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.

Secondary Outcome Measures

Name	Time	Method
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 pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.
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 freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.
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 pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.
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	Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.
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 subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.
Percentage of Migraine Attacks for Which Phonophobia 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 phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.

Trial Locations

Locations (30)

Clinvest Research; 🇺🇸 Springfield, Missouri, United States

University of Texas Southwestern Medical Center - Neurology Clinic; 🇺🇸 Dallas, Texas, United States

Primary Care Associates/Radiant Research; 🇺🇸 Anderson, South Carolina, United States

Empire Clinical Research; 🇺🇸 Upland, California, United States

Clinical Research Institute; 🇺🇸 Plymouth, Minnesota, United States

DelRicht Research; 🇺🇸 New Orleans, Louisiana, United States

Downtown L.A. Research Center; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

StudyMetrix Research LLC; 🇺🇸 Saint Peters, Missouri, United States

FutureSearch Trials of Neurology; 🇺🇸 Austin, Texas, United States

Central Texas Health Research; 🇺🇸 New Braunfels, Texas, United States

Allergy Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States

Harmony Medical Research Institute; 🇺🇸 Hialeah, Florida, United States

MedVadis Research Corporation; 🇺🇸 Watertown, Massachusetts, United States

Peters Medical Research; 🇺🇸 High Point, North Carolina, United States

Rochester Clinical Research; 🇺🇸 Rochester, New York, United States

Coastal Carolina Research Center; 🇺🇸 Mount Pleasant, South Carolina, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

North Carolina Clinical Research; 🇺🇸 Raleigh, North Carolina, United States

Albuquerque Clinical Trials; 🇺🇸 Albuquerque, New Mexico, United States

Lillestol Research; 🇺🇸 Fargo, North Dakota, United States

Raleigh Medical Group PMG Research; 🇺🇸 Raleigh, North Carolina, United States

Advanced Clinical Research; 🇺🇸 Meridian, Idaho, United States

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Colorado Allergy Asthma Centers; 🇺🇸 Denver, Colorado, United States

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

Michigan Headache and Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States