Neurocysticercosis Clinical Trial
Official title:
A Pilot Study of Neurocysticercosis Treatment
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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