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A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis

Award Number: U01AI177191
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis - Oxfendazole in Neurocysticercosis Principal Investigator/Program Director: GARCIA, Hector H. A multicenter, randomized controlled trial of single and three-dose regimens of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis SUMMARY Taenia solium neurocysticercosis (NCC), the infection of the human central nervous system by the cystic larvae of Taenia solium, continues to be a major contributor to neurologic morbidity (particularly seizures and epilepsy) in most of the developing world, and a common diagnosis in immigrant populations in the USA and other industrialized countries. Anti-parasitic treatment destroys the brain cysts and improves the prognosis of the seizure disorder. The combination of albendazole (ABZ) plus praziquantel (PZQ) is more efficacious than ABZ alone in cases with multiple viable brain cysts, and recent publications also suggest increased efficacy in individuals with mild infections (one to two lesions, by far the most form of presentation in the Indian subcontinent, as well as in pediatric populations worldwide, in travelers to endemic regions, and in non-endemic regions such as the US). Still the efficacy of the best available regimens offer less than 70% efficacy in parenchymal brain NCC with one to two lesions. The recent development of oxfendazole (OXF) as a potential anti-parasitic agent for human use may provide a new, practical tool with increased efficacy and easier administration. We will perform a three-arm double blind, randomized controlled trial in six centers in two different geographic regions, three in India and three in Peru, to evaluate whether a single dose regime of OXF results in comparable efficacy to the currently used 10 day regime of ABZ plus PZQ, and also whether a 3-dose course of OXF can offer increased parasiticidal efficacy. The study cohort will also allow identification of early imaging markers that may predict lesion resolution in response to anti-parasitic treatment, and will provide additional data on the safety of oral OXF and factors associated to residual scarring, seizure relapses, or reduced quality of life in this population. Finally, systematic sampling in the cohort will provide defined batteries of DNA, white blood cells, serum and urine samples for future evaluation of diagnostic assays for single-lesion parenchymal NCC.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $941,896 )
2025	2025	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Allergy and Infectious Diseases Research	000	3	6/23/2025	NON-COMPETING CONTINUATION	$941,896
														Subtotal = $941,896

Issue Date FY: 2024 ( Subtotal = $944,056 )
2024	2024	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Allergy and Infectious Diseases Research	000	2	6/3/2024	NON-COMPETING CONTINUATION	$944,056
														Subtotal = $944,056

Issue Date FY: 2023 ( Subtotal = $514,732 )
2023	2023	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Allergy and Infectious Diseases Research	000	1	8/28/2023	NEW	$514,732
														Subtotal = $514,732

Grand Total All Awards = $2,400,684

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A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis

Award Number: U01AI177191

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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