A Pilot Study of Neurocysticercosis Treatment
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| ClinicalTrials.gov Identifier: NCT00283699 |
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Recruitment Status :
Completed
First Posted : January 30, 2006
Last Update Posted : February 8, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurocysticercosis | Drug: albendazole Other: placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 178 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study of Neurocysticercosis Treatment |
| Study Start Date : | February 2001 |
| Actual Primary Completion Date : | February 2005 |
| Actual Study Completion Date : | February 2005 |
| Arm | Intervention/treatment |
|---|---|
Active Comparator: 1
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Drug: albendazole
Active drug or placebo dosed bid p o for 8days |
| Placebo Comparator: 2 |
Other: placebo
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 ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients presenting with new onset of symptoms associated with neurocysticercosis within two months of identification and have active and/or transitional neurocysticercosis cysts on computed tomography (CT) or magnetic resonance imaging (MRI)
Exclusion Criteria:
- Patients with only calcifications
- Patients who are pregnant
- Patients with one of the following conditions: papilledema, active tuberculosis, syphilis, ocular cysticercosis, active gastric ulcers, or a progressive and life-threatening disorder
- Patients who received anthelmintic drugs (AHD) during the year preceding presentation or who received steroids within 30 days of presentation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283699
| Ecuador | |
| Vicente Corral Moscoso Hospital of Cuenca, Centro de Epilepsia, Facultad de Ciencias Médicinas de la Universidad de Cuenca IDIUC (Área 5), Av. 12 de Abril. Cdla. | |
| Cuenca, Ecuador | |
| Teodoro Maldonado Carbo Hospital, Av. 25 de Julio Vía Puerto Marítimo | |
| Guayaquil, Ecuador | |
| Baca Ortiz Children's Hospital, Av. Colon s/n y 6 de Diciembre | |
| Quito, Ecuador | |
| Hospital Carlos Andrade Marin, Av. 10 de agosto y Bogotá | |
| Quito, Ecuador | |
| Hospital Eugenio Espejo, Servicio de Neurología, Av. Colombia s/n | |
| Quito, Ecuador | |
| Principal Investigator: | W. Allen Hauser, MD | G.H. Sergievsky Center, Columbia University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | W Allen Hauser, Professor of Neurology and Epidemiology, College of Physicians and Surgeons and Mailman School of Public Health, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00283699 History of Changes |
| Other Study ID Numbers: |
R01NS039403 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 30, 2006 Key Record Dates |
| Last Update Posted: | February 8, 2010 |
| Last Verified: | March 2008 |
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
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neurocysticercosis albendazole tape worm |
Additional relevant MeSH terms:
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Neurocysticercosis Cysticercosis Taeniasis Central Nervous System Helminthiasis Central Nervous System Parasitic Infections Parasitic Diseases Cestode Infections Helminthiasis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Albendazole |
Anthelmintics Antiparasitic Agents Anti-Infective Agents Anticestodal Agents Antiplatyhelmintic Agents Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |