A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 30
- 主要终点
- Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
M207 Microneedle System 3.8 mg
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
干预措施: M207 Microneedle System (Drug)
结局指标
主要结局
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
时间窗: 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.
次要结局
- 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)