| ID | Type | Description | Link |
|---|---|---|---|
| 05-I-N214 |
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The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).
NCC is the most common parasitic infection of the central nervous system (CNS). It is caused by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic problems may occur in a patient with NCC. Corticosteroids are the current standard of care for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat infections caused by worms; however, it is unclear if its use with the corticosteroid dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone with tapered dosing when given with albendazole, as compared to standard dexamethasone and albendazole treatment, in NCC patients.
In this open label study, patients will be randomly assigned to one of two arms. Group I will receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a 360-day period. Blood collection will occur at most visits. Group II will also undergo sputum smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on Day 360.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole. |
|
| 2 | Experimental | Participants will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Participants will also receive albendazole and omeprazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | 400 mg tablet taken orally twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative frequency of partial, generalized, and total seizures | Through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative frequency of generalized seizures | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore E. Nash, MD | Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID | Principal Investigator |
| Hector H. Garcia, MD, PhD | Department of Microbiology, Universidad Peruana Cayetano Heredia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Especializado en Ciencias Neurologicas | Lima | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16170737 | Background | Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. doi: 10.1055/s-2005-917661. | |
| 8093496 | Background | Garcia HH, Gilman R, Martinez M, Tsang VC, Pilcher JB, Herrera G, Diaz F, Alvarado M, Miranda E. Cysticercosis as a major cause of epilepsy in Peru. The Cysticercosis Working Group in Peru (CWG). Lancet. 1993 Jan 23;341(8839):197-200. doi: 10.1016/0140-6736(93)90064-n. |
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| ID | Term |
|---|---|
| D020019 | Neurocysticercosis |
| D012640 | Seizures |
| D002590 | Cestode Infections |
| ID | Term |
|---|---|
| D020809 | Central Nervous System Helminthiasis |
| D020807 | Central Nervous System Parasitic Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| D003907 | Dexamethasone |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dexamethasone |
| Drug |
6mg or 8mg taken daily |
|
| Omeprazole | Drug | 20 mg tablet taken orally daily |
|
| 2302008 | Background | Medina MT, Rosas E, Rubio-Donnadieu F, Sotelo J. Neurocysticercosis as the main cause of late-onset epilepsy in Mexico. Arch Intern Med. 1990 Feb;150(2):325-7. |
| D010272 | Parasitic Diseases |
| D003551 | Cysticercosis |
| D013622 | Taeniasis |
| D006373 | Helminthiasis |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |