ClinicalTrials.gg
RecruitingNCT00001205Updated Oct 29, 2026

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

An observational study in Cysticercosis and Neurocysticercosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 3 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionNeurocysticercosisRegistry: CysticercosisReclassifiedWhy we changed it
Registry
Cysticercosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neurocysticercosis
Why
  1. The study's listed conditions name Neurocysticercosis, a narrower term within Cysticercosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

From the registry’s dates

  • Started Oct 1985; still recruiting 41 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
3 Years to 99 Years
Sex
All
01

Study 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 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:

  1. To develop novel biomarkers associated with active infection
  2. To further understand host-parasite interactions, including the inflammatory response
  3. Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
  4. 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:

  1. Central and peripheral immune cell phenotyping and cytokine measurements
  2. Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
  3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
  4. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
02

Conditions studied

  • Cysticercosis
  • Neurocysticercosis

Browse trials for

Keywords

  • Tapeworm
  • Taenia Solium
  • Neurocysticercosis
  • Natural History
  • Seizures
  • Aseptic Meningitis
  • Hydrocephalus
03

In context

Neurocysticercosis Reclassified

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

Browse Neurocysticercosis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Compared within Neurocysticercosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cysticercosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
3 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Arms 1-5 (NCC):

  1. Aged 3 years and older.
  2. Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written document.
  3. Patients with proven or likely NCC

Arm 6 (Endemic Exposures):

  1. Patient with epidemiologic history compatible with possible exposure to NCC
  2. Aged 18 years and older.

Exclusion criteria

EXCLUSION CRITERIA:

Not applicable

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Ongoing

Secondary outcomes

  1. Central and peripheral immune cell phenotyping and cytokine measurements

    Time frame: 2-5 years

  2. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.

    Time frame: 2-5 years

  3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

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 35134144 ↗
  • Beatty 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 38680612 ↗
  • Tang 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 37347506 ↗
  • Corda 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 35617367 ↗
  • Harrison 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 33269789 ↗
  • Nash 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 32868512 ↗
  • Tang 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 39475624 ↗
  • Nash 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 31642423 ↗
  • O'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 ↗
09

Timeline

3 registry updates since Sep 25, 2026

Started Oct 1985 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Oct 7, 1985
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description
3 updates, last Oct 29, 2026
Show all 3 updates
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 2, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001205
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Oct 7, 1985
Last update
Oct 29, 2026

Study contacts

Perla M Adames Castillo, R.N.
Contact
perla.adamescastillo@nih.gov
(301) 402-8495
Elise M O'Connell, M.D.
Contact
oconnellem@mail.nih.gov
(301) 761-5413
Elise M O'Connell, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion