Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001205
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
1999-11-03
Brief Title:
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 85-I-0127 | None | None | None |