A Double-blind Multicenter, Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild (One or Two Lesions) Parenchymal Brain Cysticercosis, With an Open Comparison Group
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 544
- 主要终点
- Efficacy: completely resolution or persistance only as small lesion remnants.
研究概览
简要总结
The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy, with the potential to provide a single-dose therapy for this type of NCC.
The study cohort will also allow us to identify early imaging markers that predict lesion resolution, as well as factors associated with residual calcification or focal gliosis after lesion resolution. This study will also provide additional information on the safety of the study interventions.
详细描述
This three-arm randomized controlled phase II/III clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mg/kg oxfendazole and a regimen with three similar doses spread over seven days (day 1, day 4 and day 7), with the most effective antiparasitic regimen available, combined albendazole plus praziquantel for ten days in individuals with mild NCC (with one to two lesions).
Participants will receive treatment with oxfendazole (one or three dose regimens) or the standard treatment (albendazole + praziquantel). At day 15 after treatment onset, an MRI will be performed to evaluate early predictors of lesion resolution. MRI at day 90 will serve to evaluate efficacy (lesion resolution) and a day 180 MRI will evaluate sequelae lesions. CT will be performed at the en of the study to confirm persistence of calcified sequelae lesion.
The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions, all in a single brain area. Lesions can be one or two adjacent, viable or degenerating NCC lesions. Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement.
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
- Double (Participant, Investigator)
盲法说明
This study is a double-blind trial in regards to dose regime of OXF. Neither the investigators nor the subjects know which dose of OXF a given subject is receiving, although subjects and clinical study staff will know whether they are receiving one of the OXF regimes or active ABZ+PZQ.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female individuals between 18 and 75 years of age, with suspected viable or degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and Chandy, 1997)
- •If female of child-bearing potential and men, willing to use an adequate method of contraception*, including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.
- •Patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, ALT, and AST.
- •Availability to grant informed consent.
排除标准
- •Multiple lesion sites or more than two adjacent lesions.
- •Suspected neurotuberculosis (Rajshekhar's criteria) [66,67]
- •More than two viable brain cysts.
- •Large brain cysts (> 3cm in diameter)
- •Subarachnoid neurocysticercosis or intraventricular
- •Untreated ocular cysticercosis
- •Previous therapy with ABZ (does not include patients who received single-dose 400 mg ABZ for intestinal parasites), or PZQ in the past twelve months.
- •Active pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum smears.
- •Systemic disease other than NCC that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
- •Patients in unstable condition or with severe intracranial hypertension (ICH). Definition of severe ICH for this study would be the presence of headaches, nausea, and vomiting, and papilledema at fundoscopic examination.
- •History of hypersensitivity to ABZ or PZQ
- •Concurrent treatment with cimetidine, ranitidine, or theophylline.
- •Chronic alcohol or drug abuse.
- •Positive to Strongyloides infection
- •History of reported allergy to contrast substances used in MRI.
研究组 & 干预措施
Intervention 1
OXF 20 mg/kg/d, single dose, orally
干预措施: Oxfendazole single dose (Drug)
Intervention 2
OXF 20 mg/kg/d, for three days (1, 4 and 7), orally
干预措施: Oxfendazole three doses (Drug)
Comparison regimen
Combined treatment with albendazole (15 mg/k/d) plus praziquantel (50 mg/k/d), for 10 days, orally.
干预措施: albendazole plus praziquantel regime (Drug)
结局指标
主要结局
Efficacy: completely resolution or persistance only as small lesion remnants.
时间窗: Three months after treatment onset
Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (\<20% of the original lesion size).
Efficacy: completely resolution or persistence only as small lesion remnants.
时间窗: Three months after treatment onset
Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (\<20% of the original lesion size).
次要结局
- Clinical effectiveness: Seizure relapses.(In the initial 12 months after treatment)
- Safety: Serious adverse events(In the initial 12 months after treatment)