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A Pilot Study of Neurocysticercosis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283699
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : February 8, 2010
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Description
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Brief Summary:
The purpose of this study is to determine if treatment with albendazole improves the clinical outcome of neurocysticercosis infection and/or leads to the disappearance of cysts sooner when compared with symptomatic treatment.

Condition or disease Intervention/treatment Phase
Neurocysticercosis Drug: albendazole Other: placebo Phase 3

Detailed Description:

Neurocysticercosis—a disease in which a young tapeworm infects the brain—is common in much of the developing world. It affects approximately 1 out of every 10 people in the United States and is said to be the primary cause of adult-onset epilepsy. The infection creates cysts in the brain, causing seizures and headaches among other symptoms. To date no successful preventive treatment for neurocysticercosis exists.

At present, medicines that kill the adult tapeworm in the stomach and intestines are also used to treat neurocysticercosis caused by the young tapeworm. However, in cases of neurocysticercosis, the methods of administration, doses, and duration of treatment with these medicines still have not been determined. Although these medicines may kill the worm in the brain more rapidly than the natural mechanisms of the body, the long-term benefit of using the medicines to eliminate the worms after the first 1 or 2 months is not clear. In addition, the drugs that kill the worm may be associated with in increased seizures and headache during treatment, and may cause inflammation of the meninges—the covering of the brain—leading to symptoms that may require surgery.

The goal of this trial is to determine if treatment with the antiparasitic agent albendazole improves the outcome of neurocysticercosis infection. This trial will also determine if albendazole leads to the disappearance of cysts sooner when compared with symptomatic treatment.

Participants will be randomly assigned to receive either the study medication, albendazol, or a placebo, an inactive substance, for an 8-day inpatient or outpatient therapy period. Additionally, all participants will receive prednisolone, a corticosteroid, as well as other medications. Participants will remain under the care of a doctor for 2 years and will have regularly scheduled visits and testing.

Information learned in this study may lead to improved treatment of neurocysticercosis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neurocysticercosis Treatment
Study Start Date : February 2001
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
  1. albendazole, 15 mg/kg/day for those less than 50 kg in weight. For those more than 50 kg, 800 mg was administered. All got standard symptomatic therapy
  2. placebo plus standard symptomatic therapy
 Drug: albendazole
Active drug or placebo dosed bid p o for 8days
Placebo Comparator: 2 Other: placebo
an inactive substance


Outcome Measures
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Primary Outcome Measures :
  1. Cyst freedom [ Time Frame: 1 month, 6 months, 1 year ]

Secondary Outcome Measures :
  1. cyst reduction [ Time Frame: 1 month, 6 months, 1 year ]
  2. seizure freedom [ Time Frame: actuarial at 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with new onset of symptoms associated with neurocysticercosis within two months of identification and have active and/or transitional neurocysticercosis cysts on computed tomography (CT) or magnetic resonance imaging (MRI)

Exclusion Criteria:

  • Patients with only calcifications
  • Patients who are pregnant
  • Patients with one of the following conditions: papilledema, active tuberculosis, syphilis, ocular cysticercosis, active gastric ulcers, or a progressive and life-threatening disorder
  • Patients who received anthelmintic drugs (AHD) during the year preceding presentation or who received steroids within 30 days of presentation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283699


Locations
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Ecuador
Vicente Corral Moscoso Hospital of Cuenca, Centro de Epilepsia, Facultad de Ciencias Médicinas de la Universidad de Cuenca IDIUC (Área 5), Av. 12 de Abril. Cdla.
Cuenca, Ecuador
Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo
Guayaquil, Ecuador
Baca Ortiz Children's Hospital, Av. Colon s/n y 6 de Diciembre
Quito, Ecuador
Hospital Carlos Andrade Marin, Av. 10 de agosto y Bogotá
Quito, Ecuador
Hospital Eugenio Espejo, Servicio de Neurología, Av. Colombia s/n
Quito, Ecuador
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: W. Allen Hauser, MD G.H. Sergievsky Center, Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: W Allen Hauser, Professor of Neurology and Epidemiology, College of Physicians and Surgeons and Mailman School of Public Health, Columbia University
ClinicalTrials.gov Identifier: NCT00283699    
Other Study ID Numbers: R01NS039403 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: March 2008
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
neurocysticercosis
albendazole
tape worm
Additional relevant MeSH terms:
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Neurocysticercosis
Cysticercosis
Taeniasis
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Parasitic Diseases
Cestode Infections
Helminthiasis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Albendazole
 Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents