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

• Status: Completed
• Trial end date: 2019-05-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zosano Pharma Corporation
• Treatments: Oxazolidinones; Zolmitriptan

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