A Phase 4 interventional study of albendazole and praziquantel and Albendazole in Neurocysticercosis, sponsored by R-Evolution Worldwide S.r.l. Impresa Sociale. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by R-Evolution Worldwide S.r.l. Impresa Sociale · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.
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:
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
This study's planned enrollment of 300 is above the median of 107 across 13 interventional studies indexed under Neurocysticercosis.
Browse Neurocysticercosis studies →This is the only study on the registry with R-Evolution Worldwide S.r.l. Impresa Sociale as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: albendazole and praziquantel
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.
Drug: Albendazole
Drug pages: Albendazole · Praziquantel
Combination of albendazole plus praziquantel
Also known as: Albendazole, Praziquantel
Albendazole alone
Cyst resolution or reduction in both study arms
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.
Time frame: 6 weeks and 6 months
Seizures frequency
Reduction of seizures frequency at 6-weeks to 6-months following treatment
Time frame: 6 weeks and 6 months
Quality of Life questionnaire
The improvement in Quality of life (QoL) at 6-weeks, 6-months and 12-months following treatment.
Time frame: 6 weeks, 6 months and 1 year
Headache
The headache severity and frequency will be assessed by in-depth neurological examination, including patient-reported outcome measures (e.g. VAS - Visual Analog Scale), at the following defined time point: baseline, 6 weeks, 6 months and 1 year
Time frame: 6 weeks, 6 months and 1 year
Serological test results correlation with neuroimaging results
To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis, antigen and antibody detecting tests results will be done and the results will be compared with neuroimaging (CT/MRI), at baseline, 6-week, 6-month and 1 year following treatment.
Time frame: Baseline, 6 weeks, 6 months and 1 year
No study locations are listed for this record.
Plan to share: Yes — We plan to share the de-identified data on efficacy and safety during publication of the study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 12 months after study completion.
Access criteria: Open access
Start is estimated for Jun 2024; primary completion for Dec 2025, 18 months later.
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Studies of the drugs tested here: Albendazole · Praziquantel