RCT ALB for SA Cysticercosis

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00133458
First received: August 19, 2005
Last updated: August 26, 2010
Last verified: October 2005
  Purpose

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 Intervention Phase
Subarachnoid Cysticercosis
Drug: Albendazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Comparison of Two Lenghts of Albendazole Therapy for Subarachnoid Cysticercosis

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 120
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133458

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

No publications provided

ClinicalTrials.gov Identifier: NCT00133458     History of Changes
Other Study ID Numbers: 04-003
Study First Received: August 19, 2005
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Albenza, Subarachnoid cysticercosis

Additional relevant MeSH terms:
Cysticercosis
Neurocysticercosis
Taeniasis
Central Nervous System Diseases
Central Nervous System Helminthiasis
Central Nervous System Infections
Central Nervous System Parasitic Infections
Cestode Infections
Helminthiasis
Nervous System Diseases
Parasitic Diseases
Albendazole
Anthelmintics
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014