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Randomized Study of Albendazole in Patients with Epilepsy Due to Neurocysticercosis



Randomized Study of Albendazole in Patients with Epilepsy Due to Neurocysticercosis

For Condition: Epilepsy,Cysticercosis
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Johns Hopkins University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 16 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 120

Location and Contact Information:

Overall Study Official:
RobertGilman,  Study Chair,  Johns Hopkins University


Additional Information:
Study ID Numbers:  199/13286;  JHUSHPH-FDR001107
Study Start Date: May 2000
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004403

Other Epilepsy Studies:
1. Randomized Study of Albendazole in Patients with Epilepsy Due to Neurocysticercosis

2. Brain Tissue Swelling and Seizure Activity in Inactive Cysticercosis

3. Treatment of Patients with Cysticercosis with Praziquantel or Albendazole

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