Status:
COMPLETED
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Lead Sponsor:
Zosano Pharma Corporation
Conditions:
Migraine
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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 eD...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2019
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT03282227
Start Date
November 7 2017
End Date
May 17 2019
Last Update
August 19 2020
Active Locations (31)
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1
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
2
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
3
Downtown L.A. Research Center
Los Angeles, California, United States, 90017
4
Stanford University Medical Center
Palo Alto, California, United States, 94304