A Pilot Study of Neurocysticercosis Treatment

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00283699
Study type	Interventional
Source	National Institute of Neurological Disorders and Stroke (NINDS)
Contact
Status	Completed
Phase	Phase 3
Start date	February 2001
Completion date	February 2005

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00526916` - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28	Phase 1
Completed	`NCT00527579` - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB	Phase 1
Terminated	`NCT02233855` - People Presenting With Neurocysticercosis in North America
Recruiting	`NCT00001205` - Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Completed	`NCT02234570` - Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole	Phase 1
Terminated	`NCT02947581` - Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)	Phase 3
Completed	`NCT02243644` - Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT	Phase 3
Not yet recruiting	`NCT06376396` - Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis	Phase 4
Completed	`NCT03874689` - Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia
Completed	`NCT00441285` - Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)	Phase 2/Phase 3
Not yet recruiting	`NCT04706819` - Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Terminated	`NCT02945527` - Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)	Phase 2/Phase 3
Completed	`NCT00290823` - Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients	Phase 3
Completed	`NCT03834337` - Treatment of Patients With Active Neurocysticercosis in Eastern Africa
Completed	`NCT03851419` - The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.