A Pilot Study of Neurocysticercosis Treatment
1 other identifier
interventional
178
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2001
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedFebruary 8, 2010
March 1, 2008
4 years
January 26, 2006
February 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cyst freedom
1 month, 6 months, 1 year
Secondary Outcomes (2)
cyst reduction
1 month, 6 months, 1 year
seizure freedom
actuarial at 1 year
Study Arms (2)
1
ACTIVE COMPARATOR1. 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
2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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.
PMID: 18495737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
W. Allen Hauser, MD
G.H. Sergievsky Center, Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 30, 2006
Study Start
February 1, 2001
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
February 8, 2010
Record last verified: 2008-03