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RCT ALB for SA Cysticercosis

This study has been withdrawn prior to recruitment.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00133458
  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 III

Drug Information available for:   Albendazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:   Randomized, Double Blind Comparison of Two Lenghts of Albendazole Therapy for Subarachnoid Cysticercosis

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

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


Study ID Numbers:   04-003
First Received:   August 19, 2005
Last Updated:   June 7, 2007
ClinicalTrials.gov Identifier:   NCT00133458
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Albendazole
Central Nervous System Infections
Central Nervous System Diseases
Cysticercosis
Parasitic Diseases
Taeniasis
Neurocysticercosis
Helminthiasis

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

ClinicalTrials.gov processed this record on November 05, 2008




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