Protocol Number: 85-I-0127

Title:

Treatment of Patients with Cysticercosis with Praziquantel, Albendazole and Other Novel Treatment Modalities

Number:

85-I-0127

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

T. Solium

Cysticercosis

Praziquantel

Recruitment Keyword(s):

None

Condition(s):

Cysticercosis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Praziquantel

Drug: Albendazole

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Cimetidine-induced rise in praziquantel levels in a patient with neurocysticercosis being treated with anticonvulsants

Single-day praziquantel versus 1-week albendazole for neurocysticercosis

Albendazole and praziquantel treatment in neurocysticercosis of the fourth ventricle

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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