Clinical Trial: Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ]
Original Primary Outcome: Cumulative frequency of partial, generalized, and total seizures from Days 11 to 42
Current Secondary Outcome: Cumulative frequency of generalized seizures [ Time Frame: Throughout study ]
Original Secondary Outcome: Cumulative frequency of generalized seizures
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: February 9, 2006
Date Started: April 2006
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017
