Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Drug levels are being followed q 6-mos.
研究概览
简要总结
The purpose of this pilot study is to investigate the use of minocycline and doxycycline as medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and giant aneurysms.
详细描述
Arteriovenous malformations (AVMs) are a treatable cause of stroke in young adults. The processes by which AVMs and giant aneurysms grow in size and spontaneously bleed are unknown. The primary reason to treat AVMs and aneurysms is to guard against intracranial bleeding.
This pilot study will examine the use of two common antibiotics-minocycline and doxycycline-as medical therapy for inoperable or partially treated AVMs and giant aneurysms. These drugs, which are tetracycline derivatives, can reduce the levels of a family of enzymes, called matrix metalloproteases, that degrade tissue and thereby cause a reduction in the risk of spontaneous bleeding from AVMs or aneurysm-which is the main cause of stroke associated with these disorders. The enzymes can contribute to weaknesses in the wall of blood vessels and may increase the risk of the vessel wall rupturing and causing spontaneous bleeding.
This trial also will show that taking minocycline and doxycycline over an extended period in this patient population is safe and well tolerated. Results from this study could help plan future studies to benefit patients with abnormal blood vessels prone to bleeding in their brains.
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
- None
入排标准
- 年龄范围
- 13 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Giant aneurysms or brain arteriovenous malformations (BAVM)
- •Female patients of child bearing age using effective birth control, males
- •Creatinine no greater than 2.0 mg/dl
- •ALT no greater than 2 times upper limit of control
排除标准
- •Unstable medical illness
- •Contraindications to Tetracycline
- •History of vestibular disease, (except benign positional vertigo)
- •Prior tetracycline use within 2 mos of baseline visit.
- •History of noncompliance with treatment or other protocols
- •History of systemic lupus
- •Patients not eligible for MRI
研究组 & 干预措施
Brain AVMs
This trial is to investigate the use of minocycline or doxycycline as medical therapy, can minocycline or doxycycline induce biologically significant changes in the enzyme system thought to be related to spontaneous growth/rupture of these malformations. Finally, can patients safely tolerate these medications over an extended period of time.
干预措施: minocycline (Drug)
Brain AVMs
This trial is to investigate the use of minocycline or doxycycline as medical therapy, can minocycline or doxycycline induce biologically significant changes in the enzyme system thought to be related to spontaneous growth/rupture of these malformations. Finally, can patients safely tolerate these medications over an extended period of time.
干预措施: doxycycline (Drug)
Aneurysms
干预措施: minocycline (Drug)
Aneurysms
干预措施: doxycycline (Drug)
结局指标
主要结局
Drug levels are being followed q 6-mos.
时间窗: Patients called weekly for 1st-3 months, then every 6-months until completion of study
MRI will be done baseline and post treatment.
时间窗: 2 years
MMP levels are being followed q 6-mos.
时间窗: Patients called weekly for 1st-3 months, then every 6-months until completion of study
次要结局
未报告次要终点
