Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Cyst resolution or reduction in both study arms
研究概览
简要总结
The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.
详细描述
This is a randomized, two arms, parallel-groups, open-label clinical trial to assess if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis in Tanzania and Zambia.
Background and Study Rationale: between the forms of human cysticercosis caused by Taenia solium, neurocysticercosis is a major contributor to the burden of seizure disorders and epilepsy in most of the world, while it has relatively poor clinical evidence on treatment options, requiring further data, mainly from additional randomized controlled trials. In particular albendazole and praziquantel are the two parasiticides recommended for use in treating active neurocysticercosis (NCC). Specifically, albendazole is recommended for use in patients with a single cyst while both albendazole and praziquantel (combination therapy) are recommended for patients with multiple cysts. However, not all patients with single cysts respond to albendazole monotherapy. Combination therapy may be effective in patients with single cysts as it has already been shown effective for multiple cysts.
Most studies of treatment success for NCC have been conducted in Latin America and India. In India, the studies were performed primarily on singular cystic lesions. Despite Sub-Saharan Africa (SSA) being recognized as endemic for this parasite, no study evaluating the success of standard treatment in humans has been conducted in this region. Additionally, it is difficult to extrapolate information from other regions other than SSA due to possible differences in genetic, clinical, and environmental factors.
Primary Objective:
The primary objective of this study is to determine if the anthelmintics combination of praziquantel and albendazole is better than albendazole alone in the treatment of the active parenchymal neurocysticercosis based on cyst resolution.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in the study area for a continuous period of 3 years
- •Adult aged 18 years and above
- •Are willing and able to consent to this study
- •Meet the definitions of active symptomatic NCC
- •Have late onset of epilepsy or history of seizures, epileptic seizures
- •Subjects willing to undergo diagnostic procedures
- •Subjects medically stable enough for trial medication to be initiated
- •Subjects willing to be hospitalized for 11-20 days to receive treatment for NCC
- •Subjects willing to be followed up for one year following receipt of study medication
排除标准
- •Women pregnant or breastfeeding
- •Symptomatic NCC with cysts in extra-parenchymal location (sub-arachnoid and/or ventricles)
- •Have uncontrolled hypertension and/or diabetes
- •Have chronic consuming illness such as cancer or mental handicap to not allow them to follow the study instructions
- •Have severe immunodeficiency eg. HIV/AIDS or Autoimmune diseases
- •Already known allergies to albendazole or praziquantel
- •Subject taking part in another clinical/pharmacological study in the 30 days preceding enrollment
研究组 & 干预措施
Albendazole and Praziquantel
This arm includes combined albendazole with praziquantel, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.
干预措施: albendazole and praziquantel (Drug)
Albendazole
This arm includes albendazole monotherapy, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.
干预措施: Albendazole (Drug)
结局指标
主要结局
Cyst resolution or reduction in both study arms
时间窗: 6 weeks and 6 months
The primary objective of this study is to determine if the anthelmintic combination of praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal cysticercosis, based on cyst resolution. The cysts resolution is defined by at least 70% resolution at brain imaging (CT scan / MRI) between the baseline imagines and those at 6-week to 6-month following treatment.
次要结局
- Serological test results correlation with neuroimaging results(Baseline, 6 weeks, 6 months and 1 year)
- Quality of Life questionnaire(6 weeks, 6 months and 1 year)
- Headache(6 weeks, 6 months and 1 year)
- Seizures frequency(6 weeks and 6 months)
研究者
Dario Scaramuzzi
Director
R-Evolution Worldwide S.r.l. Impresa Sociale