Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 37
- 主要终点
- The primary effectiveness measure is the decrease in the frequency of migraine headaches.
研究概览
简要总结
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
详细描述
Migraine headache is a neurological disorder characterized by chronic and disabling headache. Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this disorder. Despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. In the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale.
A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. Typically, this opening closes shortly after birth, however, in some people, it remains open.
While there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of PFO and migraine with aura.
Comparison: This clinical study will compare PFO closure with medical therapy alone for the treatment of migraine headaches.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be between the ages of 18 and 70;
- •Patient must have a migraine history and demonstrate a refractoriness to medical treatment;
- •Patient must have a Patent Foramen Ovale (PFO);
- •Patient must be willing and able to give informed consent and complete required follow-up visits.
排除标准
- •Patient has any medical condition or receives any medication that would preclude participation in the trial
- •Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
- •Patient is pregnant, or intends to become pregnant during the trial period
研究组 & 干预措施
Test Arm with Premere investigational
PFO Closure with Premere investigational device.
干预措施: PFO Closure with Premere investigational device. (Device)
Medical management/current medications
Patients in the control group arm will not receive the medical device and will continue medical management.
干预措施: Medical management/current medications per standard of care by personal physician. (Drug)
结局指标
主要结局
The primary effectiveness measure is the decrease in the frequency of migraine headaches.
时间窗: monthly
Primary Endpoint 1: Effectiveness
时间窗: 12 months
The primary safety endpoint is the rate of major complications
时间窗: monthly
次要结局
- Secondary Endpoint 1: Effect of Aura(on-going)
- Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance(Five years)