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Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)

NCT02947581 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2022-11-16

No results posted yet for this study

Summary

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.

Conditions

  • Neurocysticercosis

Interventions

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.

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)

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Hector H. Garcia Lescano, Ph.D · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2020-08-21
Completion
2021-02-27

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947581 on ClinicalTrials.gov