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RCT ALB for SA Cysticercosis

Primary Purpose

Subarachnoid Cysticercosis

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Albendazole
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Cysticercosis focused on measuring Albenza, Subarachnoid cysticercosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Facultad de Medicina de Riberao
  • Instituto Neurologico de Antioquia
  • Neurology Service, Hospital -Clinica Kennedy
  • Universidad Peruana Cayetano Heredia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 19, 2005
Last Updated
January 28, 2019
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00133458
Brief Title
RCT ALB for SA Cysticercosis
Official Title
Randomized, Double Blind Comparison of Two Lenghts of Albendazole Therapy for Subarachnoid Cysticercosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Cysticercosis
Keywords
Albenza, Subarachnoid cysticercosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Albendazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Facultad de Medicina de Riberao
City
Riberao Preto
ZIP/Postal Code
14020-380
Country
Brazil
Facility Name
Instituto Neurologico de Antioquia
City
Medellin
Country
Colombia
Facility Name
Neurology Service, Hospital -Clinica Kennedy
City
Guayaquil
Country
Ecuador
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru

12. IPD Sharing Statement

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RCT ALB for SA Cysticercosis

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