A Pilot Study of Neurocysticercosis Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00283699
First received: January 26, 2006
Last updated: February 5, 2010
Last verified: March 2008
  Purpose

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 Intervention Phase
Neurocysticercosis
Drug: albendazole
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neurocysticercosis Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Cyst freedom [ Time Frame: 1 month, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cyst reduction [ Time Frame: 1 month, 6 months, 1 year ] [ Designated as safety issue: No ]
  • seizure freedom [ Time Frame: actuarial at 1 year ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: February 2001
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
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: NCT00283699

Locations
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
Investigators
Principal Investigator: W. Allen Hauser, MD G.H. Sergievsky Center, Columbia University
  More Information

No publications provided by National Institute of Neurological Disorders and Stroke (NINDS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
Other Study ID Numbers: R01NS039403
Study First Received: January 26, 2006
Last Updated: February 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
neurocysticercosis
albendazole
tape worm

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 30, 2014