Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis

Официальное название

Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia

Обзор

The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.

Подробное описание

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.

Secondary Objectives:

1. To determine if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis based on seizures reduction 2. To estimate the change in quality of life of patients with active symptomatic NCC before and after treatment with combined antiparasitic treatment and mono… 3. To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis.

Вмешательства

• Препарат albendazole and praziquantel
  Combination of albendazole plus praziquantel
• Препарат Albendazole
  Albendazole alone

Первичные конечные точки

• Cyst resolution or reduction in both study arms [Срок оценки: 6 weeks and 6 months]

Вторичные конечные точки (4)

• Seizures frequency [Срок оценки: 6 weeks and 6 months]
• Quality of Life questionnaire [Срок оценки: 6 weeks, 6 months and 1 year]
• Headache [Срок оценки: 6 weeks, 6 months and 1 year]
• Serological test results correlation with neuroimaging results [Срок оценки: Baseline, 6 weeks, 6 months and 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Adebayo PB, Akinyemi RO, Ogun SA, Ogunniyi A. Seizure severity and health-related quality of life of adult Nigerian patients with epilepsy. Acta Neurol Scand. 2014 Feb;129(2):102-8. doi: 10.1111/ane.12146. Epub 2013 May 18. PMID 23682560
• Azimi A, Fattahi R, Asadi-Lari M. Knowledge translation status and barriers. J Med Libr Assoc. 2015 Apr;103(2):96-9. doi: 10.3163/1536-5050.103.2.008. No abstract available. PMID 25918490
• Fogang YF, Savadogo AA, Camara M, Toffa DH, Basse A, Sow AD, Ndiaye MM. Managing neurocysticercosis: challenges and solutions. Int J Gen Med. 2015 Oct 16;8:333-44. doi: 10.2147/IJGM.S73249. eCollection 2015. PMID 26527895
• Garcia HH, Nash TE, Del Brutto OH. Clinical symptoms, diagnosis, and treatment of neurocysticercosis. Lancet Neurol. 2014 Dec;13(12):1202-15. doi: 10.1016/S1474-4422(14)70094-8. Epub 2014 Nov 10. PMID 25453460
• Kinyanjui DW, Kathuku DM, Mburu JM. Quality of life among patients living with epilepsy attending the neurology clinic at Kenyatta National Hospital, Nairobi, Kenya: a comparative study. Health Qual Life Outcomes. 2013 Jun 18;11:98. doi: 10.1186/1477-7525-11-98. PMID 23777194
• Makasi CE, Kilale AM, Ngowi BJ, Lema Y, Katiti V, Mahande MJ, Msoka EF, Stelzle D, Winkler AS, Mmbaga BT. Knowledge and misconceptions about epilepsy among people with epilepsy and their caregivers attending mental health clinics: A qualitative study in Taenia solium endemic pig-keeping communities in Tanzania. Epilepsia Open. 2023 Jun;8(2):487-496. doi: 10.1002/epi4.12720. Epub 2023 Mar 20. PMID 36896648
• Nau AL, Mwape KE, Wiefek J, Schmidt K, Abatih E, Dorny P, Praet N, Chiluba C, Schmidt H, Phiri IK, Winkler AS, Gabriel S, Blocher J. Cognitive impairment and quality of life of people with epilepsy and neurocysticercosis in Zambia. Epilepsy Behav. 2018 Mar;80:354-359. doi: 10.1016/j.yebeh.2017.10.042. Epub 2017 Dec 6. PMID 29221763
• Nyangi C, Stelzle D, Mkupasi EM, Ngowi HA, Churi AJ, Schmidt V, Mahonge C, Winkler AS. Knowledge, attitudes and practices related to Taenia solium cysticercosis and taeniasis in Tanzania. BMC Infect Dis. 2022 Jun 13;22(1):534. doi: 10.1186/s12879-022-07408-0. PMID 35692033

Идентификаторы

NCT: NCT06376396 · 101103306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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