NCT02472418已完成2 期
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
研究概览
简要总结
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders [ICHD]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;
- •Patients with onset of migraine with or without aura before age 50;
- •Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
- •Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.
排除标准
- •Patients with medication overuse headache (MOH) as defined by ICHD-228:
- •Opioids ≥ 10 days a month during the 90 days prior to screening
- •Combination medications (eg, Fiorinal® ≥ 10 days a month)
- •Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications > 14 days a month during the 90 days prior to screening
- •Triptans or ergots ≥ 10 days a month during the 90 days prior to screening
- •Patients on chronic warfarin sodium;
- •Patients taking monoamine oxidase-A (MAO-A) inhibitors;
- •Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;
- •Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);
- •Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;
- •Patients with atypical aura;
- •Patients with prolonged aura (more than 1 hour).
- •Patients with a history of stroke or transient ischemic attack;
- •Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
- •Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache or any other non-migraine headache;
- •Patients with a history of more than 10 tension-type headaches per month;
- •Patients with a history of cluster headache;
- •Patients with a diagnosis of ICHD-2 "probable migraine";
- •Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy);
- •Patients with severe renal impairment (defined as serum creatinine > 1.9 mg/dL);
- •Patients with serum total bilirubin > 1.9 mg/dL;
- •Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 times the upper limit of normal;
- •Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody.
- •Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;
- •Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection;
- •Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history [except basal cell carcinoma], systemic lupus erythematosus);
- •Patients who have participated in a clinical trial involving any medication during the past 30 days or 5 half-lives of the study medication, whichever is longer
研究组 & 干预措施
Placebo (treatment C)
Placebo Comparator
Placebo (treatment C)
干预措施: Placebo (treatment C) (Other)
DFN-15 240 mg (treatment B)
Experimental
DFN-15 240 mg (treatment B)
干预措施: DFN-15 Dose B (treatment B) (Drug)
DFN-15 120 mg (treatment A)
Experimental
DFN-15 120 mg (treatment A)
干预措施: DFN-15 Dose A (treatment A) (Drug)
结局指标
主要结局
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
时间窗: 2 hour
Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration
次要结局
未报告次要终点
研究者
研究点 (6)
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