A Pilot Study of Neurocysticercosis Treatment
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Neurocysticercosis Treatment|
- Cyst freedom [ Time Frame: 1 month, 6 months, 1 year ] [ Designated as safety issue: No ]
- cyst reduction [ Time Frame: 1 month, 6 months, 1 year ] [ Designated as safety issue: No ]
- seizure freedom [ Time Frame: actuarial at 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2001|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Active drug or placebo dosed bid p o for 8days
|Placebo Comparator: 2||
an inactive substance
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283699
|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|
|Principal Investigator:||W. Allen Hauser, MD||G.H. Sergievsky Center, Columbia University|