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Trial record 1 of 1 for:    85-i-0127
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Natural History of Treated Neurocysticercosis and Long-Term Outcomes

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ClinicalTrials.gov Identifier: NCT00001205
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date December 28, 2021
Actual Study Start Date October 7, 1985
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 12, 2019)
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 [ Time Frame: 7 years-indefinite ]
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Official Title Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Brief Summary

The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement.

Patients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include:

  • Blood tests.
  • X-rays of the head and long bones.
  • Electroencephalogram - recording of the electrical activity of the brain
  • Lumbar puncture (spinal tap) - examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
  • Eye examination.
  • Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure.
  • Computed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner.

Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Male and female subjects aged 3-99 years with likely or definite neurocysticercosis (NCC) diagnosis
Condition Cysticercosis
Intervention Not Provided
Study Groups/Cohorts 1
Male and female subjects aged 3-75 years with likely or definite neurocysticercosis (NCC) diagnosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 11, 2017)
500
Original Enrollment
 (submitted: June 23, 2005)
100
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: JeanAnne M Ware, C.R.N.P. (301) 594-3149 warejm@niaid.nih.gov
Contact: Elise M O'Connell, M.D. (301) 761-5413 oconnellem@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001205
Other Study ID Numbers 850127
85-I-0127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Elise M O'Connell, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 21, 2021