Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
albendazole
+ dexamethasone
+ phenytoin
Brain Diseases+17
+ Central Nervous System Diseases
+ Cestode Infections
Treatment Study
Summary
Study start date: May 1, 2000
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy --Prior/Concurrent Therapy-- No prior therapy for cysticercosis --Patient Characteristics-- Age: 16 to 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus Other: No unstable condition due to systemic disease or cysticercosis Not pregnant