RCT ALB for SA Cysticercosis

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Withdrawn

CT.gov ID

NCT00133458

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Cysticercosis	Drug: Albendazole	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Facultad de Medicina de Riberao	Riberao Preto	Brazil	14020-380
2	Instituto Neurologico de Antioquia	Medellin	Colombia
3	Neurology Service, Hospital -Clinica Kennedy	Guayaquil	Ecuador
4	Universidad Peruana Cayetano Heredia	Lima	Peru