Neurocysticercosis Clinical Trial
Official title:
Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
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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