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

Zosano Pharma

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: M207 Microneedle System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03282227

CP-2017-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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342 participants in 1 patient group

M207 Microneedle System 3.8 mg

Experimental group

Description:

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

Treatment:

Drug: M207 Microneedle System