RCT ALB for SA Cysticercosis

January 28, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Riberao Preto, Brazil, 14020-380
        • Facultad de Medicina de Riberao
  • Colombia
      • Medellin, Colombia
        • Instituto Neurologico de Antioquia
  • Ecuador
      • Guayaquil, Ecuador
        • Neurology Service, Hospital -Clinica Kennedy
  • Peru
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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