NCT01184508终止2 期
A Randomized, Double-Blind, Placebo Controlled Proof of Concept Study of LY2300559 in Patients With Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks
研究概览
简要总结
The primary objective of this study is to measure the change in frequency of migraine attacks per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Are migraine patients with migraine onset before 50 years of age
- •Present with diagnosis of at least 1 year with migraine attack defined by International Headache Society (IHS) guidelines
- •Have a frequency of 4 to 14 migraine attacks, with or without aura, per month (with no more than 14 headache days per month, migraine or non-migraine) for at least the last 6 months
- •Female patients of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control during the study
排除标准
- •Are currently enrolled in, or discontinued within the previous 6 months from a migraine clinical trial involving an investigational drug or device or off-label use of a drug or device
- •Are currently enrolled in, or discontinued within the previous 30 days from screening from a non-migraine clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have previously completed or withdrawn from this study or any other study investigating LY2300559
- •Have known allergies to LY2300559 or related compounds (such as montelukast)
- •Are under treatment with medication or procedures for prevention of migraine, or are taking any other medications that are excluded by the protocol
- •Have a history of alcohol or drug abuse/dependence within the past 3 months of screening or are currently using alcohol, drugs of abuse (including opioids, barbiturates, and marijuana), or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence
- •Screen positive for drugs of abuse
- •Patients with medication overuse headache as per IHS definition
- •Have a body mass index (BMI) of less than 18.5 or greater than or equal to 35.0
- •Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study medication or interfering with the interpretation of the data
- •Show evidence of serious active neuropsychiatric disease including, but not limited to, bipolar disorder, schizophrenia, psychosis, cluster B personality disorders [for example (eg), borderline personality disorder or narcissistic personality disorder], obsessive-compulsive disorder, or other serious mood, anxiety, depression, or substance/alcohol use disorders
- •Have ever in his/her lifetime attempted suicide, have any recent suicidal ideation within the last 3 months, or are at significant risk to commit suicide, as judged by the investigator
- •Show evidence or have history of neurological disease such as cerebral vascular accident, pseudotumor cerebri, multiple sclerosis, transient ischemic attack, syncopal episodes, encephalitis, or meningitis
- •Have a history or seizures other than febrile
- •Female patients who are pregnant or breast-feeding
- •Females of childbearing potential who are not using a clinically acceptable method of birth control (eg, oral contraceptives or abstinence)
- •Are unwilling or unable to comply with the use of a data collection device to directly record patient data
- •Are otherwise unable to comply with the requirements of the study
研究组 & 干预措施
LY2300559
Experimental
干预措施: LY2300559 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks
时间窗: Baseline and Month 3
The definition of a migraine (a headache lasting 4 to 72 hours) was based on the International Headache Society (IHS) diagnostic criteria. The number of migraine attacks per month was normalized to a 28-day month and calculated as the (number of migraine attacks\*28 days)/number of days in the specified month.
次要结局
- Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days(Baseline and Month 3)
- Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)(Baseline (Day 28) and Week 12 (Day 84))
- Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score(Baseline and Week 12)
- Percentage of Participants Using Breakthrough Medications(Month 3)
- Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score(Baseline and Week 12)
- Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)(Baseline and Month 3)
- Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)(Baseline(Day 28) and Week 12 (Day 84))
- Pharmacokinetics: Area Under the Plasma Concentration-Time Curve at the Steady State (AUCtau,ss) of LY2300559(Baseline and Week 8 (1 to 3 hours postdose), Weeks 2 and 4 (predose and 1 to 3 hours postdose), Week 12 (predose, 1 to 3 hours postdose, and 5 hours postdose))
- Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms(Baseline and Month 3)
研究者
研究点 (1)
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