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

Migraine Clinical Trial

— ADAM  

Official title:

A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282227
• Other study ID #: CP-2017-001
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2017
• Est. completion date: May 17, 2019

Study information

• Verified date: August 2020
• Source: Zosano Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• M207 Microneedle System
M207 Microneedle System 3.8 mg

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Primary Care Associates/Radiant Research	Anderson	South Carolina
United States	Michigan Headache and Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	University of Texas Southwestern Medical Center - Neurology Clinic	Dallas	Texas
United States	Colorado Allergy Asthma Centers	Denver	Colorado
United States	Lillestol Research	Fargo	North Dakota
United States	Harmony Medical Research Institute	Hialeah	Florida
United States	Peters Medical Research	High Point	North Carolina
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Downtown L.A. Research Center	Los Angeles	California
United States	Advanced Clinical Research	Meridian	Idaho
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Central Texas Health Research	New Braunfels	Texas
United States	DelRicht Research	New Orleans	Louisiana
United States	Stanford University Medical Center	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Clinical Research Institute	Plymouth	Minnesota
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Raleigh Medical Group PMG Research	Raleigh	North Carolina
United States	Rochester Clinical Research	Rochester	New York
United States	StudyMetrix Research LLC	Saint Peters	Missouri
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	Clinvest Research	Springfield	Missouri
United States	Empire Clinical Research	Upland	California
United States	MedVadis Research Corporation	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Zosano Pharma Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject
Secondary	Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject
Secondary	Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject
Secondary	Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject
Secondary	Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject
Secondary	Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose	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.	2 hours for each Migraine, up to 12 months for each subject