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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00001205
Other study ID # 850127
Secondary ID 85-I-0127
Status Recruiting
Phase
First received
Last updated
Start date October 7, 1985

Study information

Verified date June 17, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Perla M Adames Castillo, R.N.
Phone (301) 402-8495
Email perla.adamescastillo@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient information, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care....


Description:

The purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions. Cysticercosis is defined as an infection with the larval form of Taenia solium and includes infection of the brain (neurocysticercosis [NCC]) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment will be provided as clinically indicated. Clinical data and biospecimens will be collected during and after treatment to assess biomarkers of infection and inflammation, immunologic response to treatment, and correlations between biomarkers and results of clinically indicated diagnostic tests. In addition, we will collect information from patient-reported outcome questionnaires completed by participants to better understand the long-term effect on functional ability and determine if there is a correlation between clinical deficits with biomarkers of inflammation.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 99 Years
Eligibility - INCLUSION CRITERIA: 1. Patients ages 3 to 99 years. 2. Patients with proven or likely neurocysticercosis. 3. Willingness (of participant or legally authorized representative [LAR]) to sign consent and comply with study requirements. EXCLUSION CRITERIA: Not applicable.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135. — View Citation

Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86. — View Citation

Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proano JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7. doi: 10.1212/01.wnl.0000238514.51747.3a. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long term follow up, with the goal of documenting a disease free state off anthelmintics for 7 years To study the clinical course of cysticercosis following therapy and diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy 7 years-indefinite
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Terminated NCT02233855 - People Presenting With Neurocysticercosis in North America
Completed NCT02234570 - Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole Phase 1
Terminated NCT02947581 - Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO) Phase 3
Completed NCT02243644 - Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Phase 3
Not yet recruiting NCT06376396 - Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis Phase 4
Completed NCT03874689 - Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia
Completed NCT00441285 - Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ) Phase 2/Phase 3
Not yet recruiting NCT04706819 - Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Completed NCT00283699 - A Pilot Study of Neurocysticercosis Treatment Phase 3
Terminated NCT02945527 - Treatment of Peri-calcification Edema in Neurocysticercosis (NCC) Phase 2/Phase 3
Completed NCT00290823 - Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients Phase 3
Completed NCT03834337 - Treatment of Patients With Active Neurocysticercosis in Eastern Africa
Completed NCT03851419 - The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania