NCT03009019已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura
BioDelivery Sciences International43 个研究点 分布在 1 个国家目标入组 631 人开始时间: 2016年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 631
- 试验地点
- 43
- 主要终点
- Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)
研究概览
简要总结
Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
- •Patients who have migraine with or without aura with onset before age 50 years
- •Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
- •Subjects who are willing and able to:
- •Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
- •Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
- •Comply with all other study procedures and scheduling requirements.
排除标准
- •Minors, even if they are in the specified study age range
- •Medication overuse:
- •Opioids greater than or equal to 10 days during the 90 days prior to screening
- •Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
- •Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
- •Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
- •Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
- •Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
- •Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
- •Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody
- •Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.
研究组 & 干预措施
DFN-15 Active
Experimental
DFN-15 Active
干预措施: DFN-15 Active (Drug)
DFN-15 Placebo
Placebo Comparator
DFN-15 Placebo
干预措施: DFN-15 Placebo (Other)
结局指标
主要结局
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)
时间窗: 2 hours postdose
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
时间窗: 2 hours postdose
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
次要结局
- Time to Headache Pain Freedom Postdose (DB1 and DB2)(2 hours postdose)
- The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo(Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.)
- Change in Functional Disability Score Postdose (DB1 and DB2)(2 to 24 hours postdose)
- Sustained Headache Pain Relief Postdose (DB1 and DB2)(2 to 24 hours postdose)
- Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)(24 hours postdose)
- Time to Headache Pain Relief Postdose (DB1 and DB2)(2 hours postdose)
- Absence of Screening MBS at Time Points Postdose (DB1 and DB2)(15 minutes to 24 hours postdose)
- Headache Pain Freedom Postdose (DB1 and DB2)(15 minutes to 24 hours postdose)
- Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)(2 and 4 hours postdose)
- Headache Pain Recurrence Postdose (DB1 and DB2)(2 to 24 hours postdose)
- Use of Rescue Medication Postdose (DB1 and DB2)(2 to 24 hours postdose)
- Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)(15 minutes to 24 hours postdose)
- Headache Pain Relief Postdose (DB1 and DB2)(15 minutes to 24 hours postdose)
- Headache Pain Freedom Among BMI Category (DB1 and DB2)(2 and 4 hours postdose)
- Sustained Headache Pain Freedom Postdose (DB1 and DB2)(2 to 24 hours postdose)
- Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)(2 and 4 hours postdose)
研究者
研究点 (43)
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