A Pilot Study of Neurocysticercosis Treatment

Neurocysticercosis Clinical Trial

Official title:

A Pilot Study of Neurocysticercosis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283699
• Other study ID #: R01NS039403
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2006
• Last updated: February 5, 2010
• Start date: February 2001
• Est. completion date: February 2005

Study information

• Verified date: March 2008
• Source: National Institute of Neurological Disorders and Stroke (NINDS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis

Intervention

Drug:
• albendazole
Active drug or placebo dosed bid p o for 8days

Other:
• placebo
an inactive substance

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cyst freedom		1 month, 6 months, 1 year	No
Secondary	cyst reduction		1 month, 6 months, 1 year	No
Secondary	seizure freedom		actuarial at 1 year	No