OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- seizure freedom
研究概览
简要总结
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
详细描述
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 years and above
- •Signed informed consent form
- •Normal neurological development until onset of epilepsy
- •Onset of epilepsy between ages of 5 and 18 years
- •Presence of microfilaria in skin snip and/or antibodies against Ov16
排除标准
- •Ivermectin intake the last 9 months
- •Pregnancy or breastfeeding
- •Known or suspected allergy to Ivermectin
- •Loa Loa microfilariae in blood
- •Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with a history of cerebral malaria, meningitis or encephalitis)
- •Concomitant acute illness or chronic medication use
- •Chronic alcohol/substance use
研究组 & 干预措施
ivermectin once a year
Ivermectin one dose per year and anti-epileptic treatment
干预措施: ivermectin (Drug)
ivermectin 2 times a year
Ivermectin one dose 2 times a year and anti-epileptic treatment
干预措施: ivermectin (Drug)
ivermectin 3 times a year
vermectin one dose 3 times a year and anti-epileptic treatment
干预措施: ivermectin (Drug)
结局指标
主要结局
seizure freedom
时间窗: month 9-12
no seizures
次要结局
未报告次要终点
研究者
Robert Colebunders
Prof
Universiteit Antwerpen