Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
NCT ID: NCT06376396
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2024-06-30
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
albendazole and praziquantel
Combination of albendazole plus praziquantel
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.
Albendazole
Albendazole alone
Interventions
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albendazole and praziquantel
Combination of albendazole plus praziquantel
Albendazole
Albendazole alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Muhimbili University of Health and Allied Sciences
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Sokoine University of Agriculture
OTHER
University of Zambia
OTHER
University Ghent
OTHER
R-Evolution Worldwide S.r.l. Impresa Sociale
OTHER
Responsible Party
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Dario Scaramuzzi
Director
Principal Investigators
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Kabemba E. Mwape, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Zambia
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Owolabi LF, Adamu B, Jibo AM, Owolabi SD, Imam AI, Alhaji ID. Neurocysticercosis in people with epilepsy in Sub-Saharan Africa: A systematic review and meta-analysis of the prevalence and strength of association. Seizure. 2020 Jan 7;76:1-11. doi: 10.1016/j.seizure.2020.01.005. Online ahead of print.
Stelzle D, Makasi C, Schmidt V, Trevisan C, van Damme I, Welte TM, Ruether C, Fleury A, Dorny P, Magnussen P, Zulu G, Mwape KE, Bottieau E, Gabriel S, Ngowi BJ, Winkler AS; SOLID collaborators. Epidemiological, clinical and radiological characteristics of people with neurocysticercosis in Tanzania-A cross-sectional study. PLoS Negl Trop Dis. 2022 Nov 28;16(11):e0010911. doi: 10.1371/journal.pntd.0010911. eCollection 2022 Nov.
Torgerson PR, Devleesschauwer B, Praet N, Speybroeck N, Willingham AL, Kasuga F, Rokni MB, Zhou XN, Fevre EM, Sripa B, Gargouri N, Furst T, Budke CM, Carabin H, Kirk MD, Angulo FJ, Havelaar A, de Silva N. World Health Organization Estimates of the Global and Regional Disease Burden of 11 Foodborne Parasitic Diseases, 2010: A Data Synthesis. PLoS Med. 2015 Dec 3;12(12):e1001920. doi: 10.1371/journal.pmed.1001920. eCollection 2015 Dec.
Trevisan C, Damme IV, Ngowi B, Schmidt V, Stelzle D, Moller KS, Kabululu M, Makasi CE, Magnussen P, Bottieau E, Abatih E, Johansen MV, Ngowi H, Ndawi B, Mwape KE, Zulu G, Dorny P, Winkler AS, Gabriel S, On Behalf Of The Solid Consortium. Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania. Diagnostics (Basel). 2021 Aug 24;11(9):1528. doi: 10.3390/diagnostics11091528.
Braae UC, Saarnak CF, Mukaratirwa S, Devleesschauwer B, Magnussen P, Johansen MV. Taenia solium taeniosis/cysticercosis and the co-distribution with schistosomiasis in Africa. Parasit Vectors. 2015 Jun 12;8:323. doi: 10.1186/s13071-015-0938-7.
Related Links
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WHO guidelines on management of Taenia solium neurocysticercosis
Other Identifiers
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101103306
Identifier Type: -
Identifier Source: org_study_id
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