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| ID | Type | Description | Link |
|---|---|---|---|
| JHUSHPH-FDR001107 |
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OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis.
II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain.
III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either albendazole and dexamethasone or placebo.
Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year. Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15.
Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3 months for 3 years.
Completion date provided represents the completion date of the grant per OOPD records
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albendazole | Drug | |||
| dexamethasone | Drug | |||
| phenytoin | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Name | Affiliation | Role |
|---|---|---|
| Robert H. Gilman | Johns Hopkins University | Study Chair |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D003551 | Cysticercosis |
| D007154 | Immune System Diseases |
| D003141 | Communicable Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D010272 | Parasitic Diseases |
| D035583 | Rare Diseases |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013622 | Taeniasis |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| D003907 | Dexamethasone |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D002590 |
| Cestode Infections |
| D006373 | Helminthiasis |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | 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 |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |