Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283699
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2006-01-26
Brief Title:
A Pilot Study of Neurocysticercosis Treatment
Sponsor:
Columbia University
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
A Pilot Study of Neurocysticercosis Treatment
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treatment with albendazole improves the clinical outcome of neurocysticercosis infection andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None