Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO) (SANTO)
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|ClinicalTrials.gov Identifier: NCT02947581|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neurocysticercosis||Drug: Albendazole and praziquantel Drug: Albendazole and praziquantel placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
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).
Drug: Albendazole and praziquantel
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.
Other Name: ABZ+PZQ
Active Comparator: Comparison regime
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).
Drug: Albendazole and praziquantel placebo
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)
Other Name: ABZ+PZQ PCB
- Radiological efficacy at three months (3-month improvement). [ Time Frame: Day 90 +/- 15 days ]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.
- Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3). [ Time Frame: Day 180 +/- 15 days ]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).
- 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) [ Time Frame: Day 365 +/- 15 days ]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.
- Clinically asymptomatic patient [ Time Frame: 3, 6, and 12 months ]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.
- Decrease in serum levels [ Time Frame: 3 months ]will be measured at 3 months, and expressed as a proportion of the baseline level. This variable will be compared between arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947581
|Contact: Hector H. Garcia Lescano, Ph.D||(511) email@example.com|
|Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas||Recruiting|
|Lima, Peru, Lima 1|
|Contact: Isidro Gonzales, MD +511 3288589 firstname.lastname@example.org|
|Principal Investigator:||Hector H. Garcia Lescano, Ph.D||Universidad Peruana Cayetano Heredia|