Status:
COMPLETED
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Neurocysticercosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 pat...
Detailed Description
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 oc...
Eligibility Criteria
Inclusion
- Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)
- Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry
- Willingness to be hospitalized for a minimum of 2 weeks for this study
- PPD negative OR negative smears for tuberculosis (TB) if PPD positive
- Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy
Exclusion
- Primary generalized seizures not caused by NCC
- Subarachnoid or ventricular NCC
- Any vesicular lesion greater than 2 cm in diameter
- Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.
- Intracranial hypertension, as confirmed by CT or MRI
- History of status epilepticus
- Focal neurological defects
- Unstable or consistently abnormal vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure)
- Cysts in critical regions, including brainstem or the eyes
- Pulmonary TB
- History of TB in the patient or history of TB in close contact of patient
- Chest x-ray suggestive of past or current TB
- Diabetes
- Systemic conditions (e.g., chronic kidney failure, liver disease, heart failure, steroid-dependent immune diseases) other than NCC that may interfere with the study
- Predicted survival time of less than 1 year
- Inability to undergo CT or MRI
- Hypersensitivity to albendazole, antiepileptic drugs, or contrast
- Hypertension at rest
- Require corticosteroids, received corticosteroids in the 4 weeks prior to study entry, or received corticosteroids for 9 or more days within the 6 months prior to study entry
- Other CNS processes that may interfere with study assessments
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00290823
Start Date
April 1 2006
End Date
March 1 2011
Last Update
February 3 2017
Active Locations (1)
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1
Instituto Especializado en Ciencias Neurologicas
Lima, Peru