Phase 3
Completed N=342
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT03282227 ↗Enrolled (actual)
342
Serious AEs
1.5%
Results posted
Aug 2020
Primary outcomePrimary: Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months — 323 Participants
◆ Published Evidence
Emerging
15citations · ~3 / year
Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine.
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.
Linked Publications
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Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months |
323 | — |
| SECONDARY Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose |
2477 | — |
| SECONDARY Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose |
3315 | — |
| SECONDARY Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose |
4552 | — |
| SECONDARY Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose |
4628 | — |
| SECONDARY Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose |
3410 | — |
| SECONDARY Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose |
3563 | — |
Eligibility Criteria
Main 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.
Main 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
- Diabetes mellitus
- History or current abuse or dependence on alcohol or drugs
Data sourced from ClinicalTrials.gov (NCT03282227) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.