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A Pilot Study of Neurocysticercosis Treatment

Primary Purpose

Neurocysticercosis

Status
Completed
Phase
Phase 3
Locations
Ecuador
Study Type
Interventional
Intervention
albendazole
placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurocysticercosis focused on measuring neurocysticercosis, albendazole, tape worm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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.
  • Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo
  • Baca Ortiz Children's Hospital, Av. Colon s/n y 6 de Diciembre
  • Hospital Carlos Andrade Marin, Av. 10 de agosto y Bogotá
  • Hospital Eugenio Espejo, Servicio de Neurología, Av. Colombia s/n

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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 placebo plus standard symptomatic therapy

Outcomes

Primary Outcome Measures

Cyst freedom

Secondary Outcome Measures

cyst reduction
seizure freedom

Full Information

First Posted
January 26, 2006
Last Updated
February 5, 2010
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00283699
Brief Title
A Pilot Study of Neurocysticercosis Treatment
Official Title
A Pilot Study of Neurocysticercosis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocysticercosis
Keywords
neurocysticercosis, albendazole, tape worm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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 placebo plus standard symptomatic therapy
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
albendazole
Intervention Description
Active drug or placebo dosed bid p o for 8days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
Cyst freedom
Time Frame
1 month, 6 months, 1 year
Secondary Outcome Measure Information:
Title
cyst reduction
Time Frame
1 month, 6 months, 1 year
Title
seizure freedom
Time Frame
actuarial at 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Allen Hauser, MD
Organizational Affiliation
G.H. Sergievsky Center, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
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.
City
Cuenca
Country
Ecuador
Facility Name
Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo
City
Guayaquil
Country
Ecuador
Facility Name
Baca Ortiz Children's Hospital, Av. Colon s/n y 6 de Diciembre
City
Quito
Country
Ecuador
Facility Name
Hospital Carlos Andrade Marin, Av. 10 de agosto y Bogotá
City
Quito
Country
Ecuador
Facility Name
Hospital Eugenio Espejo, Servicio de Neurología, Av. Colombia s/n
City
Quito
Country
Ecuador

12. IPD Sharing Statement

Citations:
PubMed Identifier
18495737
Citation
Carpio A, Kelvin EA, Bagiella E, Leslie D, Leon P, Andrews H, Hauser WA; Ecuadorian Neurocysticercosis Group. Effects of albendazole treatment on neurocysticercosis: a randomised controlled trial. J Neurol Neurosurg Psychiatry. 2008 Sep;79(9):1050-5. doi: 10.1136/jnnp.2008.144899. Epub 2008 May 21.
Results Reference
derived

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A Pilot Study of Neurocysticercosis Treatment

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