A Pilot Study of Neurocysticercosis Treatment

February 5, 2010 updated by: Columbia University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

178

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

  • Ecuador
      • Cuenca, 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.
      • Guayaquil, Ecuador
        • Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo
      • Quito, 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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Other: placebo
an inactive substance
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cyst freedom
Time Frame: 1 month, 6 months, 1 year
1 month, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
cyst reduction
Time Frame: 1 month, 6 months, 1 year
1 month, 6 months, 1 year
seizure freedom
Time Frame: actuarial at 1 year
actuarial at 1 year

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: W. Allen Hauser, MD, G.H. Sergievsky Center, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Start

February 1, 2001

Primary Completion (ACTUAL)

February 1, 2005

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (ESTIMATE)

January 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 5, 2010

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NS039403 (NIH)

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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