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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001205 |
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:
Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.
Condition | Intervention |
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Cysticercosis |
Drug: Praziquantel Drug: Albendazole |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Cysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities |
Estimated Enrollment: | 100 |
Study Start Date: | July 1985 |
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.
Ages Eligible for Study: | 1 Year to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Theodore E. Nash, M.D./National Institute of Allergy and Infectious Diseases ) |
Study ID Numbers: | 850127, 85-I-0127 |
Study First Received: | November 3, 1999 |
Last Updated: | October 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00001205 |
Health Authority: | United States: Federal Government |
T. Solium Cysticercosis Praziquantel |
Albendazole Central Nervous System Infections Central Nervous System Diseases Cysticercosis Praziquantel |
Parasitic Diseases Taeniasis Neurocysticercosis Helminthiasis |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiplatyhelmintic Agents Central Nervous System Helminthiasis Mitosis Modulators Nervous System Diseases Anthelmintics |
Antimitotic Agents Central Nervous System Parasitic Infections Pharmacologic Actions Anticestodal Agents Antiparasitic Agents Therapeutic Uses Tubulin Modulators Cestode Infections |