Clinical Trial: A Pilot Study of Neurocysticercosis Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study of Neurocysticercosis 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 Summary:
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 t
Sponsor: Columbia University
Current Primary Outcome: Cyst freedom [ Time Frame: 1 month, 6 months, 1 year ]
Original Primary Outcome: Cyst disappearance at 1, 6, and 12 months comparing the two treatment groups.
Current Secondary Outcome:
- cyst reduction [ Time Frame: 1 month, 6 months, 1 year ]
- seizure freedom [ Time Frame: actuarial at 1 year ]
Original Secondary Outcome:
- Seizure recurrence as estimated by Kaplan Meyer curves. This will be measured at last follow-up. Patients will be followed a minimum of 1 year, a maximum of 2 years.
- Relative reduction in number of cysts at 1,6, and 12 months comparing the two treatment groups.
Information By: National Institute of Neurological Disorders and Stroke (NINDS)
Dates:
Date Received: January 26, 2006
Date Started: February 2001
Date Completion:
Last Updated: February 5, 2010
Last Verified: March 2008
