CysticercosisNCT00001205
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
An observational study of Cysticercosis and Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cysticercosis, Neurocysticercosis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 1985to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Arms 1-5 (neurocysticercosis arms): male and female subjects over age 3 years with likely or definite neurocysticercosis (NCC) diagnosis 2. Arm 6 (endemic exposure arm): subjects 18 years or older with an epidemiologic history compatible with possible exposure to Taenia solium.
Who may be able to join
- Arms 1-5 (NCC):
- Aged 3 years and older.
- Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
- Patients with proven or likely NCC
- Arm 6 (Endemic Exposures):
- Patient with epidemiologic history compatible with possible exposure to NCC
- Aged 18 years and older.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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 clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.
Read the detailed description
Study 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.
Primary Objective:
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Secondary Objectives:
- To develop novel biomarkers associated with active infection
- To further understand host-parasite interactions, including the inflammatory response
- Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
- Develop a screening paradigm
Primary Endpoint:
Description of clinical presentation, imaging features, morbidity, response to treatment, and outcomes in all forms of NCC.
Secondary Endpoints:
- Central and peripheral immune cell phenotyping and cytokine measurements
- Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
- Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
- Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
- Conditions
- Cysticercosis, Neurocysticercosis
- Keywords
- Tapeworm, Taenia Solium, Neurocysticercosis, Natural History, Seizures, Aseptic Meningitis, Hydrocephalus
- Medical subject headings
- Cysticercosis, Neurocysticercosis, Cestode Infections, Taeniasis, Seizures, Meningitis, Aseptic, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Subarachnoid (racemose) neurocysticercosis | |
| Arm 2 | Ventricular without other viable disease | |
| Arm 3 | Parenchymal cyst(s)--non-calcified parenchymal disease at time of referral | |
| Arm 4 | Calcified parenchymal disease with symptoms (seizures) | |
| Arm 5 | Calcified parenchymal disease without symptoms | |
| Arm 6 | Endemic exposure--subjects with compatible epidemiologic exposure to T. solium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
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
Measured: Ongoing
Secondary outcomes (3)
Central and peripheral immune cell phenotyping and cytokine measurements
Measured: 2-5 years
Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
Measured: 2-5 years
Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start7 Oct 1985
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CysticercosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elise M O'Connell, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001205
- Sponsor's protocol ID
- 850127
- Other IDs
- 85-I-0127
- Status last verified
- 26 Aug 2026
- First submitted
- 3 Nov 1999
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McAleese KR, Guzman JJ, Thumm L, Nutman TB, Showler A, O'Connell EM. Chagas Disease Prevalence in a Cohort of Neurocysticercosis Patients in a Nonendemic Setting. Clin Infect Dis. 2022 Sep 14;75(5):897-900. doi: 10.1093/cid/ciac076.
PubMed 35134144Beatty NL, Kaur H, Schlaffer K, Thompson K, Manavalan P, Rijos ZR, Raman AA, Droghini HR, O'Connell EM. Subarachnoid Neurocysticercosis Case Series Reveals a Significant Delay in Diagnosis-Requiring a High Index of Suspicion Among Those at Risk. Open Forum Infect Dis. 2024 Mar 21;11(5):ofae176. doi: 10.1093/ofid/ofae176. eCollection 2024 May.
PubMed 38680612Tang NL, Nash TE, Corda M, Nutman TB, O'Connell EM. Triplex ELISA for Assessing Durability of Taenia solium Seropositivity after Neurocysticercosis Cure. Emerg Infect Dis. 2023 Jul;29(7):1340-1348. doi: 10.3201/eid2907.230364.
PubMed 37347506Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May.
PubMed 35617367Harrison S, Thumm L, Nash TE, Nutman TB, O'Connell EM. The Local Inflammatory Profile and Predictors of Treatment Success in Subarachnoid Neurocysticercosis. Clin Infect Dis. 2021 May 4;72(9):e326-e333. doi: 10.1093/cid/ciaa1128.
PubMed 33269789Nash TE, O'Connell EM. Subarachnoid neurocysticercosis: emerging concepts and treatment. Curr Opin Infect Dis. 2020 Oct;33(5):339-346. doi: 10.1097/QCO.0000000000000669.
PubMed 32868512Tang NL, Schaughency P, Gazzinelli-Guimaraes P, Lack J, Thumm L, Miltenberger E, Nash TE, Nutman TB, O'Connell EM. Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200320. doi: 10.1212/NXI.0000000000200320. Epub 2024 Oct 30.
PubMed 39475624Nash TE, O'Connell EM, Hammoud DA, Wetzler L, Ware JM, Mahanty S. Natural History of Treated Subarachnoid Neurocysticercosis. Am J Trop Med Hyg. 2020 Jan;102(1):78-89. doi: 10.4269/ajtmh.19-0436.
PubMed 31642423O'Connell EM, Harrison S, Dahlstrom E, Nash T, Nutman TB. A Novel, Highly Sensitive Quantitative Polymerase Chain Reaction Assay for the Diagnosis of Subarachnoid and Ventricular Neurocysticercosis and for Assessing Responses to Treatment. Clin Infect Dis. 2020 Apr 15;70(9):1875-1881. doi: 10.1093/cid/ciz541.
PubMed 31232448
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Treated Neurocysticercosis and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT00001205
- Acronym / sponsor ID
- 850127
- Conditions
- Cysticercosis, Neurocysticercosis
- Keywords
- Tapeworm, Taenia Solium, Neurocysticercosis, Natural History, Seizures, Aseptic Meningitis, Hydrocephalus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Oct 1985 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.
Detailed description
Study 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.
Primary Objective:
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Secondary Objectives:
- To develop novel biomarkers associated with active infection
- To further understand host-parasite interactions, including the inflammatory response
- Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
- Develop a screening paradigm
Primary Endpoint:
Description of clinical presentation, imaging features, morbidity, response to treatment, and outcomes in all forms of NCC.
Secondary Endpoints:
- Central and peripheral immune cell phenotyping and cytokine measurements
- Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
- Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
- Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | –Subarachnoid (racemose) neurocysticercosis |
| Arm 2 | – | –Ventricular without other viable disease |
| Arm 3 | – | –Parenchymal cyst(s)--non-calcified parenchymal disease at time of referral |
| Arm 4 | – | –Calcified parenchymal disease with symptoms (seizures) |
| Arm 5 | – | –Calcified parenchymal disease without symptoms |
| Arm 6 | – | –Endemic exposure--subjects with compatible epidemiologic exposure to T. solium |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Arms 1-5 (neurocysticercosis arms): male and female subjects over age 3 years with likely or definite neurocysticercosis (NCC) diagnosis 2. Arm 6 (endemic exposure arm): subjects 18 years or older with an epidemiologic history compatible with possible exposure to Taenia solium.
Key inclusion criteria (7 listed)
- Aged 3 years and older.
- Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
- Patients with proven or likely NCC
- Patient with epidemiologic history compatible with possible exposure to NCC
- Aged 18 years and older.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Time frame: Ongoing
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
3 secondary outcomes
Central and peripheral immune cell phenotyping and cytokine measurements
Time frame: 2-5 years
Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
Time frame: 2-5 years
Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
Time frame: Ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 35134144McAleese KR, Guzman JJ, Thumm L, Nutman TB, Showler A, O'Connell EM. Chagas Disease Prevalence in a Cohort of Neurocysticercosis Patients in a Nonendemic Setting. Clin Infect Dis. 2022 Sep 14;75(5):897-900. doi: 10.1093/cid/ciac076.
- Background: PubMed 38680612Beatty NL, Kaur H, Schlaffer K, Thompson K, Manavalan P, Rijos ZR, Raman AA, Droghini HR, O'Connell EM. Subarachnoid Neurocysticercosis Case Series Reveals a Significant Delay in Diagnosis-Requiring a High Index of Suspicion Among Those at Risk. Open Forum Infect Dis. 2024 Mar 21;11(5):ofae176. doi: 10.1093/ofid/ofae176. eCollection 2024 May.
- Background: PubMed 37347506Tang NL, Nash TE, Corda M, Nutman TB, O'Connell EM. Triplex ELISA for Assessing Durability of Taenia solium Seropositivity after Neurocysticercosis Cure. Emerg Infect Dis. 2023 Jul;29(7):1340-1348. doi: 10.3201/eid2907.230364.
- Background: PubMed 35617367Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May.
- Background: PubMed 33269789Harrison S, Thumm L, Nash TE, Nutman TB, O'Connell EM. The Local Inflammatory Profile and Predictors of Treatment Success in Subarachnoid Neurocysticercosis. Clin Infect Dis. 2021 May 4;72(9):e326-e333. doi: 10.1093/cid/ciaa1128.
- Background: PubMed 32868512Nash TE, O'Connell EM. Subarachnoid neurocysticercosis: emerging concepts and treatment. Curr Opin Infect Dis. 2020 Oct;33(5):339-346. doi: 10.1097/QCO.0000000000000669.
- Background: PubMed 39475624Tang NL, Schaughency P, Gazzinelli-Guimaraes P, Lack J, Thumm L, Miltenberger E, Nash TE, Nutman TB, O'Connell EM. Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200320. doi: 10.1212/NXI.0000000000200320. Epub 2024 Oct 30.
- Background: PubMed 31642423Nash TE, O'Connell EM, Hammoud DA, Wetzler L, Ware JM, Mahanty S. Natural History of Treated Subarachnoid Neurocysticercosis. Am J Trop Med Hyg. 2020 Jan;102(1):78-89. doi: 10.4269/ajtmh.19-0436.
- Background: PubMed 31232448O'Connell EM, Harrison S, Dahlstrom E, Nash T, Nutman TB. A Novel, Highly Sensitive Quantitative Polymerase Chain Reaction Assay for the Diagnosis of Subarachnoid and Ventricular Neurocysticercosis and for Assessing Responses to Treatment. Clin Infect Dis. 2020 Apr 15;70(9):1875-1881. doi: 10.1093/cid/ciz541.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise M O'Connell, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cysticercosis and Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perla M Adames Castillo, R.N. ((301) 402-8495, perla.adamescastillo@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001205, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.