RCT ALB for SA Cysticercosis

NCT00133458 | Withdrawn Phase 3

• 1 other identifier: 04-003
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 4

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.

Conditions

Subarachnoid Cysticercosis

Keywords

Albenza, Subarachnoid cysticercosis

Interventions

Albendazole DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Facultad de Medicina de Riberao

Riberao Preto, 14020-380, Brazil

Location

Instituto Neurologico de Antioquia

Medellín, Colombia

Location

Neurology Service, Hospital -Clinica Kennedy

Guayaquil, Ecuador

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

MeSH Terms

Interventions

Albendazole

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Completion: June 1, 2007
• Last Updated: January 30, 2019

Record last verified: 2005-10

Locations

CO (1); EC (1); PE (1); BR (1)