Official Title: “Treatment of Patients With Cysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities”

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.

Study Type: Interventional

Study Design: Treatment

The purpose of this protocol is to allow evaluation, treatment and follow up of patients with cysticercosis. Cysticercosis is defined as an infection with the larvae form of T.solium and includes infection of the brain (neurocysticercosis) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment follows accepted clinical practice and information learned is observational. Two drugs, praziquantel and albendazole, have been used extensively in the treatment of cysticercosis and are the accepted therapies. Albendazole has recently been approved for the treatment of cysticercosis while praziquantel is not approved by the FDA but has proven efficacy and safety. To decrease the provoked inflammation which can be induced by treatment or to decrease inflammation in active disease, corticosteroids or other immunosuppressive agents may be used. Anti seizure medications are also commonly used.

Intervention(s) in this Clinical Trial

• Drug: Praziquantel
  • N/A
• Drug: Albendazole
  • N/A

Primary Measures

• Duration of enrollment will be dependent on the patient's response to therapy.

INCLUSION CRITERIA:

• Patients aged 1 to 75 years will be considered for therapy. Children under age 18 normally will be eligible for use of immunosuppressives other than corticosteroids. Children who have cysticercosis and are younger than age 18 years are rarely seen at the clinical center; therefore, use of these medications in children will require a special exemption.
• Patients with proven or likely neurocysticercosis. The diagnosis of neurocysticercosis depends the presence of cysts by MRI or CT scan and/or the presence of typical calcifications by CT. Serology is usually, but not necessarily, positive.
• Willing to sign consent and be seen at prescribed intervals.

Exclusions:

• 1. Less than 1 year of age.
• 2. Unwilling to undergo effective birth control measures if use of anthelmintics or immunosuppressives (other than corticosteroids) is required.
• 3. Breast feeding if antihelmintics or immunosuppressive medications are required.
• 4. Allergic to albendazole and praziquantel
• 5. Active tuberculosis or strongyloides or other infections made worse with immunosuppression or other infections LIKELY TO BE made worse.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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

Overall Clinical Trial Officials and Contacts

Overall Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001205

Study ID Number: 850127

ClinicalTrials.gov Identifier: NCT00001205

Health Authority: United States: Federal Government

NIH Clinical Center Detailed Web Page