A Single-Site, Double-Blind, Placebo-Controlled Cross-Over Trial Examining the Safety and Efficacy of Olanzapine Taken Daily for the Prevention of Episodic Migraine.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
研究概览
简要总结
Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental for the purposes of this research study.
The Jefferson Headache Center at Thomas Jefferson University has developed this clinical study to evaluate the safety and effectiveness of Olanzapine in preventing 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
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
- •Subjects who are male or female between the ages of 18 and 65, inclusive
- •Subjects who have a history of migraine with or without aura as defined by IHS criteria, for at least one year prior to screening
- •Subjects who experience between 3 and 10 migraine attacks per month, for the three months preceding screening
- •Subjects who have no more than 15 headache days per month
- •Subjects who have been on a stable dose (no clinically significant changes) of all daily medications, for any indication, from 28 days prior to screening through the duration of the trial.
- •Women who are using, or agree to use for the duration of the study, a medically acceptable form of contraception (as determined by the investigator), if female of childbearing potential.
- •Subjects who are able to understand and comply with all study requirements
- •Subjects who provide written informed consent prior to any study procedures being performed.
排除标准
- •Women who are pregnant or lactating
- •Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability (subjects with QTC interval greater than 450ms will be excluded)
- •Subjects currently taking, or have taken within the thirty days prior to screening, any neuroleptics > 1 day per week (such as Geodon, Zyprexa, Compazine, Phenergan, Seroquel and other drugs in the same class)
- •Subjects currently taking or have taken within 4-weeks prior to screening any medication for the prevention of migraine
- •Subjects who have failed more than two adequate trials of migraine prophylaxis, as determined by investigator
- •Subjects who experience significant orthostatic hypotension, as determined by the investigator
- •Subjects who, in the investigators opinion, have a history or have evidence of a medical condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- •Subjects who, in the investigators opinion, have a history or have evidence of a psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial.
- •Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
研究组 & 干预措施
Olanzapine then Placebo
Olazepam
干预措施: Olanzapine during first intervention period and placebo during second intervention period (Drug)
Placebo then olanzapine
干预措施: Placebo during first intervention period, then olanzapine during second intervention period (Drug)
结局指标
主要结局
Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.
时间窗: 84 day period on placebo compared to 84 day period on olanzapine
Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present\*. Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112.
次要结局
- Reduction of Migraine Attack Frequency During Each 28-day Interval of the Active Treatment Period as Compared to Each 28-day Interval of the Placebo Treatment Period, Per Subject. Individual Migraine Attacks Are Separated by 48-hours Pain Free Time. A(each 28 day interval of active treatment c ompared to placebo)
- Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.(84 day period on olanzapine compared to 84 day period on placebo)