Not provided
Not provided
Not provided
Not provided
Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological disease in most of the world. When parasites locate in the cavities around the brain (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal presentation. Current treatment regimens for SANCC have quite limited efficacy. The investigators propose to compare the current standard of care (a single antiparasitic drug, albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador, and one in Brasil.
Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
In short, this is a parallel group study with a dichotomous primary outcome variable. The main analysis will compare the proportions of patients obtaining the primary outcome at 6 months, using a Chi-square test in a bivariate analysis. A similar analysis will be used for the proportions of patients with a good clinical outcome, and the proportions of patients in whom lesion resolution sustains when assessed at month 12. A Student T test analysis will be used to compare for reduction in parasite volume and non-parametric Mann-Whitney test will be alternatively applied for non-normally distributed data. A non-parametric Spearman's Rho test will be used to assess the correlation between the proportions of cyst mass reduction with the decrease in antigen levels in each study group. A Chi-square test in a bivariate analysis will evaluate the association between negative antigen levels at 6 months versus the complete disappearance of cyst mass.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventions | Experimental | Albendazole and praziquantel. Albendazole: 15 mg/k/d up to 800 mg/d (days 1 to 20), followed by 15 mg/k/d up to 1200 mg/d (day 21 to 30) and prazicuantel (50 mg/k/d days 1 to 15). |
|
| Comparison regime | Active Comparator | Albendazole and praziquantel placebo. Albendazole: 15 mg/k/d (days 1 to 30) and prazicuantel placebo in similar doses 50 mg/k/d (days 1 to 15). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole and praziquantel | Drug | Intervention - PZQ (50 mg/k/d, up to 3600 mg/d, for 15 days), as an add-on to ABZ treatment (15 mg/k/d, up to 800 mg/d for days 1-20, up to 1200 mg/d for days 21-30). In order to maintain the double blind nature of the trial, ABZ placebo will be administered to individuals over 53 kg of weight until completing the equivalent doses in the comparison group. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological efficacy at three months (3-month improvement). | Thirty percent or greater decrease in the combined volume of all parasitic masses, evaluated by contrast-enhanced MRI 3 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification. | Day 90 +/- 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3). | Total disappearance or greater than 50% decrease in the combined volume of subarachnoid parasites, evaluated by contrast-enhanced MRI 6 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification. three.months after treatment onset (comparative between treatment arms). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hector H. Garcia Lescano, Ph.D | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas | Lima | Lima 1 | Peru | |||
| Hospital Nacional Cayetano Heredia |
Anonymized patient data will be shared upon request and review by the project leaders.
Available: December 2021, until December 2023
The information will be shared upon requested by interested researchers
Not provided
Not provided
| ID | Term |
|---|---|
| D020019 | Neurocysticercosis |
| ID | Term |
|---|---|
| D020809 | Central Nervous System Helminthiasis |
| D020807 | Central Nervous System Parasitic Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D015766 | Albendazole |
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
Not provided
Not provided
Tablets containing placebo for PZQ and placebo for ABZ will be purchased from the same commercial sources than those containing active drug if possible. As much as possible, they should have the same size, appearance, excipient, smell, and taste as those containing active drug. A preliminary evaluation of the potential for distinction of active drug and placebo by patients will be performed by the investigators before randomization of the drugs and placebos to their individual coded packages. If distinguishable, a new lot will be ordered.
|
|
| Albendazole and praziquantel placebo | Drug | PZQ placebo in similar doses, given during the initial 15 days of ABZ treatment at standard doses (15 mg/k/d up to 1200 mg/d for 30 days) |
|
|
| Day 180 +/- 15 days |
| Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) | No reappearance or re-growth of the parasitic lesions on contrast enhanced MRI at 12 months after therapy onset, recorded as a dichotomous outcome. hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist 12 months post treatment. | Day 365 +/- 15 days |
| Clinically asymptomatic patient | No evidence of uncontrolled seizures, chronic severe headaches, intracranial hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist at 3, 6, and 12 months post treatment. | 3, 6, and 12 months |
| Decrease in serum levels | will be measured at 3 months, and expressed as a proportion of the baseline level. This variable will be compared between arms | 3 months |
| Lima |
| Peru |
| D010272 | Parasitic Diseases |
| D003551 | Cysticercosis |
| D013622 | Taeniasis |
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |