NCT00530517已完成2 期
A Multi-Center, Open-Label, Single-dose, Single-Arm Study to Evaluate the Usability of Subcutaneously Administered Sumatriptan Delivered Via the Intraject® System in Adult Patients During Acute Migraine Attack
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
研究概览
简要总结
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study participation will last one month and include 2 doctor visits and 2-4 phone calls.
详细描述
This study will evaluate how patients will interact with the needle-free Intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of migraine with an average of ≥2 to ≤6 attacks/month
- •Female subjects of child-bearing potential must agree to use acceptable birth control
- •Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
- •Fluent in the spoken and written English language
- •Provide written informed consent to participate in the study and be willing to comply with the study procedures
- •Access to a telephone for call center interactions
排除标准
- •A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
- •Other significant underlying cardiovascular diseases including uncontrolled hypertension
- •Hemiplegic or basilar migraine
- •A history or diagnosis of severe hepatic or renal impairment
- •A history of epilepsy or seizure or other serious neurologic condition
- •A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
- •A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
- •Tattoos in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
- •Birthmark or other significant skin discoloration in the thigh or abdominal area large enough to restrict injection site selection and/or evaluation
- •Pregnancy or breast-feeding
- •Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
研究组 & 干预措施
1
Experimental
干预措施: Intraject Sumatriptan (Device)
结局指标
主要结局
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
时间窗: 30 Days
次要结局
未报告次要终点
研究者
研究点 (4)
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