A Phase 3 interventional study of albendazole and placebo in Neurocysticercosis, sponsored by Columbia University. Completed at 5 sites in Ecuador. Per ClinicalTrials.gov, last updated 2010-02-08.
Sponsored by Columbia University · Phase 3, Interventional, and Treatment
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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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
This study's enrollment of 178 is above the median of 107 across 13 interventional studies indexed under Neurocysticercosis.
Browse Neurocysticercosis studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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1. albendazole, 15 mg/kg/day for those less than 50 kg in weight. For those more than 50 kg, 800 mg was administered. All got standard symptomatic therapy 2. placebo plus standard symptomatic therapy
Drug: albendazole
Other: placebo
Active drug or placebo dosed bid p o for 8days
an inactive substance
Cyst freedom
Time frame: 1 month, 6 months, 1 year
cyst reduction
Time frame: 1 month, 6 months, 1 year
seizure freedom
Time frame: actuarial at 1 year
The record gives a start of Feb 2001, a primary completion of Feb 2005 and a completion of Feb 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albendazole