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Combined Albendazole Plus Praziquantel in Subarachnoid NCC, DCC Application

Award Number: U01NS086968
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2015
PERIOD OF PERFORMANCE END DATE: 07/31/2023

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Combined Albendazole Plus Praziquantel in Subarachnoid NCC, DCC Application - DESCRIPTION (provided by applicant): Neurocysticercosis (NCC) is the infection of the human nervous system by the larvae of the pork tapeworm Taenia solium. Subarachnoid neurocysticercosis (SANCC) accounts for 20-35% of all NCC cases. It is an aggressive, progressive and frequently lethal presentation of NCC, endemic in most non-Muslim developing countries. Unlike intraparenchymal disease (where the predominant manifestation is seizures and epilepsy, and parasites are located in the brain tissue), in subarachnoid disease the presence of the parasitic masses in the surroundings of the brain, their growth, and the concomitant inflammatory process lead to mass effect, intracranial hypertension and/or hydrocephalus, resulting in heavy morbidity and significant mortality which can be more than 20%. The response to antiparasitic treatment in SANCC is usually slow and partial, but if complete parasite resolution is obtained patients may be cured without further symptoms. This application naturally expands the scope of and applies the knowledge obtained from a recent NINDS-funded trial on combined albendazole (ABZ) plus praziquantel (PZQ) treatment of intraparenchymal NCC [R01 NS054805]. The current treatment regimens for SANCC have quite limited efficacy and the disease is still associated with significant mortality in many places of te world. Combining ABZ and PZQ, along with appropriate steroid coverage and other safety measures, is the logical next step to improve the management of subarachnoid NCC and has not been examined before in a controlled trial. In this double-blind, randomized, placebo-controlled study, 164 patients with subarachnoid cysticercosis of the basal cisterns or the Sylvain fissure, will be assigned to either the standard of care anti- parasitic regime (30-day ABZ at 15 mg/k/d) or a combined regime adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The primary study endpoint is the proportion of patients with disappearance of their parasitic lesions in neuroimaging at six months after therapy onset. Secondary outcomes include the decrease in volume of parasitic masses measured by MRI at 3 and 6 months after treatment onset, clinical improvement evaluated as the proportion of patients asymptomatic and without need for further antiparasitic treatment 6 months post-treatment, the frequency of serious adverse events (SAE) of the combined regime compared to the standard of care, the decrease in the serum levels of circulating parasitic antigen at 3 and 6 months after treatment onset, and the proportion of patients whose lesions resolve and do not relapse by 12 months after treatment onset. The trial will initially involve four centers: two in Peru, one in Brasil and one in Ecuador with the potential to expand to more centers if required. By comparing two active regimes, the proposed parallel group design permits open assessment of control neuroimaging scans for patient safety without affecting treatment blinding, and will provide the first data to support either therapeutic change or maintenance of the standard of care. If this tril succeeds, it will provide a new, more appropriate standard of care, available worldwide.


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: 2024 ( Subtotal = -$24,134 )
2024	2020	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	2/19/2024	NON-COMPETING CONTINUATION	$0
2024	2020	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	5/17/2024	NON-COMPETING CONTINUATION	-$24,134
														Subtotal = -$24,134

Issue Date FY: 2020 ( Subtotal = $80,335 )
2020	2020	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430	LIMA	LIMA	15102		PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	7/22/2020	NON-COMPETING CONTINUATION	$80,335
														Subtotal = $80,335

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	9/25/2019	NON-COMPETING CONTINUATION	$0
2019	2018	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	8/26/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $80,335 )
2018	2018	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	7/30/2018	NON-COMPETING CONTINUATION	$80,335
														Subtotal = $80,335

Issue Date FY: 2017 ( Subtotal = $80,335 )
2017	2017	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/15/2017	NON-COMPETING CONTINUATION	$80,335
														Subtotal = $80,335

Issue Date FY: 2016 ( Subtotal = $80,850 )
2016	2016	UNIVERSIDAD PERUANA CAYETANO	Av Honorio Delgado 430, Urb Ingenie	LIMA				PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	7/29/2016	NON-COMPETING CONTINUATION	$80,850
														Subtotal = $80,850

Issue Date FY: 2015 ( Subtotal = $81,000 )
2015	2015	UNIVERSIDAD PERUANA CAYETANO	Av Honorio Delgado 430, Urb Ingenie	LIMA				PER	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/31/2015	NEW	$81,000
														Subtotal = $81,000

Grand Total All Awards = $378,721

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Combined Albendazole Plus Praziquantel in Subarachnoid NCC, DCC Application

Award Number: U01NS086968

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2015

PERIOD OF PERFORMANCE END DATE: 07/31/2023

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