Clinical trial NCT00283699: A Pilot Study of Neurocysticercosis Treatment
Official title: A Pilot Study of Neurocysticercosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurocysticercosis
Keywords: neurocysticercosis
albendazole
tape worm
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-01-30
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cyst freedom
timeFrame: 1 month, 6 months, 1 year
Secondary outcomes:
measure: cyst reduction
timeFrame: 1 month, 6 months, 1 year
measure: seizure freedom
timeFrame: actuarial at 1 year
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: 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: Guayaquil
country: Ecuador
facility: Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo
city: Quito
country: Ecuador
facility: Baca Ortiz Children's Hospital, Av. Colon s/n y 6 de Diciembre
city: Quito
country: Ecuador
facility: Hospital Carlos Andrade Marin, Av. 10 de agosto y Bogotá
city: Quito
country: Ecuador
facility: Hospital Eugenio Espejo, Servicio de Neurología, Av. Colombia s/n
Study officials:
affiliation: G.H. Sergievsky Center, Columbia University
name: W. Allen Hauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.