RCT ALB for SA Cysticercosis

Condition(s) targeted: Subarachnoid Cysticercosis

Intervention: Albendazole (Drug)

Phase: Phase 3

Status: Withdrawn

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

This study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named Taenia solium. Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. This study will determine if two months of albendazole (ABZ) therapy is better than one-month. The study will last 3 years.

Official title: Randomized, Double Blind Comparison of Two Lenghts of Albendazole Therapy for Subarachnoid Cysticercosis

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Detailed description: This is a randomized, double blind comparison of two lengths of albendazole thereapy for subarachnoid cysticercosis. It will enroll 120 individuals, male and female age 18 to 65, and diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named Taenia solium. Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. This study will determine if two months of albendazole (ABZ) therapy is better than one-month. The study will last 3 years.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female individuals between 18-65 year of age with a diagnosis of basal

subarachnoid cysticercosis, based on MRI and confirmed by serological test.

- Willingness to accomplish the two weeks minimal hospitalization required.

- Female of child-bearing potential willing to use an adequate method of contraception

including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.

- Patients with normal laboratory values for hemoglobin, platelet counts, total white

blood cells, glucose, creatinine, bilirubin, ALT, AST, and electrolytes.

- Negative fecal exam for Taenia eggs.

Exclusion Criteria:

- Previous therapy with albendazole (does not include patients who received single-dose

400 mg ABZ for intestinal parasites), or praziquantel.

- Pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum

smears.

- Pre-existing diagnosis of diabetes

- Systemic disease other than NCC that may affect therapy or short-term prognosis,

including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases. Identification of systemic diseases will be left to the discretion of each Site PI.

- Patients in unstable condition or with severe intracranial hypertension (ICH).

Definition of severe ICH for this study would be the presence of headaches, nausea, and vomiting and papilledema at fundoscopic examination (all of them). Patients in this category can be considered for entrance into the study only after treatment of ICH by ventricle-peritoneal shunting. Patients with CT findings compatible with intracranial hypertension will have neurosurgical evaluation (by non study personal) before study entry.

- Pregnancy

- History of hypersensitivity to albendazole

- Concurrent treatment with praziquantel, cimetidine or teophylline.

- Chronic alcohol or drug abuse

Facultad de Medicina de Riberao, Riberao Preto 14020-380, Brazil

Instituto Neurologico de Antioquia, Medellin, Colombia

Neurology Service, Hospital -Clinica Kennedy, Guayaquil, Ecuador

Universidad Peruana Cayetano Heredia, Lima, Peru

Ending date: June 2007
Last updated: June 7, 2007