A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
Overview
- Phase
- Phase 3
- Intervention
- M207 Microneedle System
- Conditions
- Migraine
- Sponsor
- Zosano Pharma Corporation
- Enrollment
- 342
- Locations
- 30
- Primary Endpoint
- Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
M207 Microneedle System 3.8 mg
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Intervention: M207 Microneedle System
Outcomes
Primary Outcomes
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
Time Frame: 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 Outcomes
- 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 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 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 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 Nausea 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 Was Achieved at 2 Hours Post-dose(2 hours for each Migraine, up to 12 months for each subject)